Diabetic Macular Edema
Conditions
Brief summary
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Interventions
DRUGAflibercept
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
DRUGFaricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
PROCEDURESham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of diabetes mellitus (Type 1 or Type 2) * Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1 * Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea * Decreased visual acuity attributable primarily to DME * Ability and willingness to undertake all scheduled visits and assessments * For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion criteria
* Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1 * Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest * Currently pregnant or breastfeeding, or intend to become pregnant during the study * Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye * Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye * Prior administration of IVT faricimab in either eye * Active intraocular or periocular infection or active intraocular inflammation in the study eye * Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye * Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye * Other protocol-specified inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | From Baseline through Week 56 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 95% CI is a rounding of 95.04% CI. |
| Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best-Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Baseline, average of Weeks 48, 52, and 56 | BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Baseline, average of Weeks 48, 52, and 56 | BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Baseline, average of Weeks 48, 52, and 56 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Baseline, average of Weeks 48, 52, and 56 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Baseline, average of Weeks 48, 52, and 56 | BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Baseline, average of Weeks 48, 52, and 56 | BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Baseline, average of Weeks 48, 52, and 56 | BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement invisual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Baseline, Weeks 16, 52, and 96 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 16, 52, and 96 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Baseline, Weeks 16, 52, and 96 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 16, 52, and 96 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Baseline, Weeks 16, 52, and 96 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 16, 52, and 96 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations | Baseline and Week 52 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). PDR was defined as an ETDRS DRSS score of ≥61 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted percentages of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI. |
| Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations | Baseline and Week 52 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced PDR. High-risk PDR was defined as an ETDRS DRSS score of ≥71 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI. |
| Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population | Week 52 | — |
| Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population | Week 52 | — |
| Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population | Week 96 | — |
| Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population | Week 96 | — |
| Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations | From start of PTI (Week 12 or later) until Week 52 | — |
| Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations | From start of PTI (Week 12 or later) until Week 96 | — |
| Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | From Baseline through Week 56 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Average of Weeks 48, 52, and 56 | Absence of diabetic macular edema was defined as achieving a central subfield thickness (CST) of \<325 microns in the study eye. CST was defined as the distance between the internal limiting membrane and Bruch's membrane. For each participant, an average CST value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Absence of diabetic macular edema was defined as achieving a central subfield thickness of \<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100 | Retinal dryness was defined as achieving a central subfield thickness (ILM-BM) of \<280 microns. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100 | Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100 | Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
| Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations | Baseline and Week 52 | The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 97.5% confidence interval (CI) is a rounding of 97.52% CI. |
| Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Baseline, Weeks 24, 52, and 100 | The NEI VFQ-25 captures a patient's perception of vision-related functioning and quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and one item on general health. The composite score ranges from 0 to 100, with higher scores, or a positive change from baseline, indicating better vision-related functioning. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% CI is a rounding of 95.04% CI. |
| Percentage of Participants With at Least One Adverse Event | From first dose of study drug through end of study (up to 2 years) | This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation. |
| Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | From first dose of study drug through end of study (up to 2 years) | This analysis of adverse events (AEs) only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation. |
| Percentage of Participants With at Least One Non-Ocular Adverse Event | From first dose of study drug through end of study (up to 2 years) | This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. |
| Plasma Concentration of Faricimab Over Time | Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100 | Faricimab concentration in plasma was determined using a validated immunoassay method. |
| Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Baseline, Weeks 4, 28, 52, 76, and 100 | Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period. |
| Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100 | Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI. |
Countries
Austria, Bulgaria, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Russia, Slovakia, Spain, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A: Faricimab 6 mg Q8W Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100. | 315 |
| B: Faricimab 6 mg PTI Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100. | 313 |
| C: Aflibercept 2 mg Q8W Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100. | 312 |
| Total | 940 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 | 5 |
| Overall Study | Death | 16 | 21 | 13 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 12 | 9 | 9 |
| Overall Study | Other | 2 | 0 | 3 |
| Overall Study | Physician Decision | 3 | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 12 | 7 | 19 |
Baseline characteristics
| Characteristic | A: Faricimab 6 mg Q8W | B: Faricimab 6 mg PTI | C: Aflibercept 2 mg Q8W | Total |
|---|---|---|---|---|
| Age, Continuous ITT Population | 61.6 Years STANDARD_DEVIATION 9.5 | 62.8 Years STANDARD_DEVIATION 10 | 62.2 Years STANDARD_DEVIATION 9.6 | 62.2 Years STANDARD_DEVIATION 9.7 |
| Age, Continuous Treatment-Naive Population | 61.0 Years STANDARD_DEVIATION 9.6 | 62.5 Years STANDARD_DEVIATION 10.3 | 62.2 Years STANDARD_DEVIATION 9.9 | 61.9 Years STANDARD_DEVIATION 10 |
| Baseline Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye ITT Population | 62.0 ETDRS Letters STANDARD_DEVIATION 9.9 | 61.9 ETDRS Letters STANDARD_DEVIATION 10.2 | 62.2 ETDRS Letters STANDARD_DEVIATION 9.5 | 62.0 ETDRS Letters STANDARD_DEVIATION 9.9 |
| Baseline Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye Treatment-Naive Population | 62.3 ETDRS Letters STANDARD_DEVIATION 9.9 | 61.8 ETDRS Letters STANDARD_DEVIATION 10.7 | 62.6 ETDRS Letters STANDARD_DEVIATION 9.2 | 62.2 ETDRS Letters STANDARD_DEVIATION 9.9 |
| Baseline Central Subfield Thickness in the Study Eye ITT Population | 492.3 microns STANDARD_DEVIATION 135.8 | 485.8 microns STANDARD_DEVIATION 130.8 | 484.5 microns STANDARD_DEVIATION 131.1 | 487.5 microns STANDARD_DEVIATION 132.5 |
| Baseline Central Subfield Thickness in the Study Eye Treatment-Naive Population | 488.8 microns STANDARD_DEVIATION 136.8 | 483.5 microns STANDARD_DEVIATION 127.3 | 486.8 microns STANDARD_DEVIATION 130.4 | 486.3 microns STANDARD_DEVIATION 131.3 |
| Ethnicity (NIH/OMB) ITT Population Hispanic or Latino | 37 Participants | 40 Participants | 37 Participants | 114 Participants |
| Ethnicity (NIH/OMB) ITT Population Not Hispanic or Latino | 273 Participants | 268 Participants | 272 Participants | 813 Participants |
| Ethnicity (NIH/OMB) ITT Population Unknown or Not Reported | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Treatment-Naive Population Hispanic or Latino | 31 Participants | 32 Participants | 31 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Treatment-Naive Population Not Hispanic or Latino | 202 Participants | 210 Participants | 208 Participants | 620 Participants |
| Ethnicity (NIH/OMB) Treatment-Naive Population Unknown or Not Reported | 5 Participants | 3 Participants | 3 Participants | 11 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 10 - High Risk PDR (DRS Level 75) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 11 - Advanced PDR (DRS Level 81) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 12 - Advanced PDR (DRS Level 85) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 1 - Diabetic Retinopathy (DR) Absent | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 2 - DR Questionable / Microaneurysms Only | 4 Participants | 6 Participants | 10 Participants | 20 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 3 - Mild Non-Proliferative Diabetic Retinopathy (NPDR) | 84 Participants | 92 Participants | 83 Participants | 259 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 4 - Moderate NPDR | 84 Participants | 86 Participants | 85 Participants | 255 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 5 - Moderately Severe NPDR | 67 Participants | 59 Participants | 54 Participants | 180 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 6 - Severe NPDR | 46 Participants | 40 Participants | 49 Participants | 135 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 7 - Mild Proliferative Diabetic Retinopathy (PDR) | 16 Participants | 11 Participants | 9 Participants | 36 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 8 - Moderate PDR | 6 Participants | 9 Participants | 7 Participants | 22 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population 9 - High Risk PDR (DRS Level 71) | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population Cannot Grade | 4 Participants | 5 Participants | 7 Participants | 16 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye ITT Population Missing | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 10 - High Risk PDR (DRS Level 75) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 11 - Advanced PDR (DRS Level 81) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 12 - Advanced PDR (DRS Level 85) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 1 - Diabetic Retinopathy (DR) Absent | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 2 - DR Questionable / Microaneurysms Only | 1 Participants | 4 Participants | 4 Participants | 9 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 3 - Mild Non-Proliferative Diabetic Retinopathy (NPDR) | 65 Participants | 66 Participants | 57 Participants | 188 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 4 - Moderate NPDR | 56 Participants | 58 Participants | 65 Participants | 179 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 5 - Moderately Severe NPDR | 50 Participants | 52 Participants | 48 Participants | 150 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 6 - Severe NPDR | 40 Participants | 38 Participants | 46 Participants | 124 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 7 - Mild Proliferative Diabetic Retinopathy (PDR) | 13 Participants | 9 Participants | 6 Participants | 28 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 8 - Moderate PDR | 6 Participants | 9 Participants | 6 Participants | 21 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population 9 - High Risk PDR (DRS Level 71) | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population Cannot Grade | 4 Participants | 5 Participants | 5 Participants | 14 Participants |
| Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye Treatment-Naive Population Missing | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Number of Participants by Previous Treatment Status with Intravitreal Anti-VEGF Agents Previously Treated | 77 Participants | 68 Participants | 70 Participants | 215 Participants |
| Number of Participants by Previous Treatment Status with Intravitreal Anti-VEGF Agents Treatment-Naive | 238 Participants | 245 Participants | 242 Participants | 725 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye ITT Population ≤38 Letters | 15 Participants | 12 Participants | 12 Participants | 39 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye ITT Population 39 to 63 Letters | 132 Participants | 126 Participants | 132 Participants | 390 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye ITT Population ≥64 Letters | 168 Participants | 175 Participants | 168 Participants | 511 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye ITT Population Missing/Invalid BCVA | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye Treatment-Naive Population ≤38 Letters | 10 Participants | 11 Participants | 8 Participants | 29 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye Treatment-Naive Population 39 to 63 Letters | 98 Participants | 95 Participants | 100 Participants | 293 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye Treatment-Naive Population ≥64 Letters | 130 Participants | 139 Participants | 134 Participants | 403 Participants |
| Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye Treatment-Naive Population Missing/Invalid BCVA | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants by the Eye Chosen as the Study Eye (Left or Right) ITT Population Left Eye | 150 Participants | 172 Participants | 151 Participants | 473 Participants |
| Number of Participants by the Eye Chosen as the Study Eye (Left or Right) ITT Population Right Eye | 165 Participants | 141 Participants | 161 Participants | 467 Participants |
| Number of Participants by the Eye Chosen as the Study Eye (Left or Right) Treatment-Naive Population Left Eye | 117 Participants | 130 Participants | 117 Participants | 364 Participants |
| Number of Participants by the Eye Chosen as the Study Eye (Left or Right) Treatment-Naive Population Right Eye | 121 Participants | 115 Participants | 125 Participants | 361 Participants |
| Race (NIH/OMB) ITT Population American Indian or Alaska Native | 6 Participants | 5 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) ITT Population Asian | 31 Participants | 26 Participants | 27 Participants | 84 Participants |
| Race (NIH/OMB) ITT Population Black or African American | 22 Participants | 25 Participants | 12 Participants | 59 Participants |
| Race (NIH/OMB) ITT Population More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) ITT Population Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) ITT Population Unknown or Not Reported | 13 Participants | 16 Participants | 10 Participants | 39 Participants |
| Race (NIH/OMB) ITT Population White | 241 Participants | 240 Participants | 253 Participants | 734 Participants |
| Race (NIH/OMB) Treatment-Naive Population American Indian or Alaska Native | 4 Participants | 3 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Treatment-Naive Population Asian | 21 Participants | 18 Participants | 20 Participants | 59 Participants |
| Race (NIH/OMB) Treatment-Naive Population Black or African American | 17 Participants | 24 Participants | 9 Participants | 50 Participants |
| Race (NIH/OMB) Treatment-Naive Population More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Treatment-Naive Population Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Treatment-Naive Population Unknown or Not Reported | 13 Participants | 13 Participants | 9 Participants | 35 Participants |
| Race (NIH/OMB) Treatment-Naive Population White | 181 Participants | 186 Participants | 196 Participants | 563 Participants |
| Region of Enrollment ITT Population Asia | 21 Participants | 19 Participants | 20 Participants | 60 Participants |
| Region of Enrollment ITT Population Rest of the World | 127 Participants | 126 Participants | 124 Participants | 377 Participants |
| Region of Enrollment ITT Population United States and Canada | 167 Participants | 168 Participants | 168 Participants | 503 Participants |
| Region of Enrollment Treatment-Naive Population Asia | 14 Participants | 14 Participants | 15 Participants | 43 Participants |
| Region of Enrollment Treatment-Naive Population Rest of the World | 94 Participants | 97 Participants | 92 Participants | 283 Participants |
| Region of Enrollment Treatment-Naive Population United States and Canada | 130 Participants | 134 Participants | 135 Participants | 399 Participants |
| Sex: Female, Male ITT Population Female | 128 Participants | 116 Participants | 134 Participants | 378 Participants |
| Sex: Female, Male ITT Population Male | 187 Participants | 197 Participants | 178 Participants | 562 Participants |
| Sex: Female, Male Treatment-Naive Population Female | 93 Participants | 91 Participants | 108 Participants | 292 Participants |
| Sex: Female, Male Treatment-Naive Population Male | 145 Participants | 154 Participants | 134 Participants | 433 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 16 / 313 | 21 / 313 | 13 / 311 |
| other Total, other adverse events | 161 / 313 | 163 / 313 | 163 / 311 |
| serious Total, serious adverse events | 111 / 313 | 117 / 313 | 93 / 311 |
Outcome results
Primary
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI.
Time frame: From Baseline through Week 56
Population: ITT Population and Treatment-Naive Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 10.7 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 10.6 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 11.6 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 11.4 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 10.9 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 11.3 ETDRS Letters |
Comparison: Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.97.5% CI: [-2, 1.6]
Comparison: Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.97.5% CI: [-1.1, 2.5]
Comparison: Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.p-value: 0.469997.5% CI: [-2.8, 1.4]Mixed Model for Repeated Measures
Comparison: Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.p-value: 0.96597.5% CI: [-2.1, 2.2]Mixed Model for Repeated Measures
Comparison: Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.p-value: 0.796797.5% CI: [-2, 1.6]Mixed Model for Repeated Measures
Comparison: Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.p-value: 0.377297.5% CI: [-1.1, 2.5]Mixed Model for Repeated Measures
Secondary
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 95% CI is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 64 | 10.7 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 36 | 10.1 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 8 | 7.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 60 | 10.3 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 40 | 10.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 24 | 10.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 56 | 10.8 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 44 | 9.9 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 88 | 9.8 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 48 | 10.5 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 12 | 8.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 52 | 9.9 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 84 | 9.9 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 100 | 10.5 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 80 | 10.9 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 20 | 9.6 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 96 | 11.1 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 76 | 10.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 4 | 5.5 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 72 | 10.4 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 28 | 9.5 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 16 | 9.1 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 68 | 10.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 32 | 10.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 92 | 10.5 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 100 | 10.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 4 | 6.7 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 8 | 8.2 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 16 | 10.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 20 | 9.9 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 24 | 11.3 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 28 | 11.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 32 | 10.9 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 36 | 11.7 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 40 | 11.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 44 | 11.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 48 | 11.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 52 | 11.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 56 | 11.6 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 60 | 12.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 64 | 11.5 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 68 | 11.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 72 | 11.3 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 76 | 11.5 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 80 | 11.1 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 84 | 11.5 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 88 | 10.9 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 92 | 11.2 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 96 | 10.6 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 12 | 9.2 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 88 | 11.0 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 68 | 11.3 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 24 | 9.4 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 4 | 6.5 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 72 | 10.7 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 20 | 9.8 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 96 | 11.1 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 76 | 11.0 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 16 | 9.7 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 92 | 11.5 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 80 | 10.9 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 12 | 9.1 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 48 | 10.8 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 100 | 11.6 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 52 | 10.9 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 40 | 10.3 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 84 | 11.8 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 56 | 10.6 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 36 | 10.4 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 8 | 8.1 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 60 | 11.3 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 32 | 10.2 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 44 | 10.7 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 64 | 10.8 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, ITT Population | Week 28 | 10.5 ETDRS Letters |
Secondary
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Best-Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 10.3 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 10.3 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 9.6 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 10.3 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 7.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 10.0 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 10.5 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 10.6 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 10.1 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 8.5 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 10.1 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 10.3 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 9.4 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 10.9 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 9.6 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 10.6 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 9.3 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 11.1 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 9.9 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 9.7 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 10.5 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 5.8 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 10.2 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 9.6 ETDRS Letters |
| A: Faricimab 6 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 10.1 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 11.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 9.7 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 10.7 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 11.2 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 6.8 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 8.3 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 9.3 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 10.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 11.2 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 11.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 10.9 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 11.9 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 11.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 11.4 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 11.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 11.5 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 12.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 11.5 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 11.3 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 11.3 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 11.0 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 11.6 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 10.8 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 10.5 ETDRS Letters |
| B: Faricimab 6 mg PTI | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 10.5 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 11.6 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 11.4 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 9.8 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 10.6 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 10.8 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 10.1 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 8.7 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 10.8 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 9.6 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 11.7 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 11.1 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 6.9 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 11.4 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 11.9 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 11.0 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 11.3 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 11.2 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 10.3 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 11.3 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 10.9 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 11.6 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 10.7 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 10.6 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 11.0 ETDRS Letters |
| C: Aflibercept 2 mg Q8W | Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 11.0 ETDRS Letters |
Secondary
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: From Baseline through Week 56
Population: ITT Population and Treatment-Naive Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | -206.6 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | -204.6 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | -196.5 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | -197.5 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | -170.3 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | -173.6 microns |
Comparison: This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.95% CI: [-47.8, -24.7]
Comparison: This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.95% CI: [-37.7, -14.7]
Comparison: This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.95% CI: [-43.6, -18.6]
Comparison: This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.95% CI: [-36.2, -11.6]
Secondary
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 72 | -216.2 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 32 | -200.2 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 8 | -145.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 56 | -212.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 36 | -179.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 92 | -210.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 12 | -165.6 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 40 | -205.1 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 24 | -196.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 28 | -174.6 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 44 | -187.5 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 96 | -224.0 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 4 | -118.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 48 | -209.7 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 84 | -211.8 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 16 | -177.6 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 52 | -191.0 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 60 | -197.8 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 76 | -206.0 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 100 | -213.1 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 64 | -214.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 80 | -219.1 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 88 | -218.6 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 68 | -201.1 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 20 | -184.6 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 68 | -200.9 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 72 | -201.6 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 20 | -174.6 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 76 | -200.7 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 56 | -200.3 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 80 | -203.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 84 | -204.9 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 24 | -192.8 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 88 | -204.1 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 92 | -202.4 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 96 | -203.8 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 28 | -193.7 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 100 | -207.3 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 52 | -193.0 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 8 | -149.6 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 32 | -181.6 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 36 | -201.0 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 40 | -193.5 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 12 | -168.4 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 44 | -189.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 48 | -194.8 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 60 | -196.3 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 16 | -182.1 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 64 | -199.9 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 4 | -124.9 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 100 | -200.2 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 52 | -179.2 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 56 | -164.4 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 4 | -111.0 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 8 | -130.9 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 12 | -144.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 16 | -152.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 20 | -159.0 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 24 | -146.3 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 28 | -163.8 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 32 | -147.2 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 36 | -166.0 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 40 | -153.9 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 44 | -172.6 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 48 | -163.2 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 60 | -182.0 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 64 | -171.5 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 68 | -186.8 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 72 | -182.3 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 76 | -188.4 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 80 | -184.5 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 84 | -186.2 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 88 | -183.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 92 | -193.9 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population | Week 96 | -194.7 microns |
Secondary
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 16 | -175.1 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 68 | -201.5 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 40 | -198.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 100 | -213.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 4 | -116.1 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 44 | -187.3 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 88 | -215.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 60 | -195.0 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 48 | -207.3 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 20 | -182.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 64 | -213.7 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 52 | -191.1 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 96 | -221.0 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 56 | -210.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 84 | -211.0 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 24 | -194.2 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 12 | -162.8 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 80 | -217.3 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 28 | -177.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 8 | -142.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 76 | -204.8 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 32 | -196.4 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 92 | -208.8 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 72 | -215.9 microns |
| A: Faricimab 6 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 36 | -181.9 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 64 | -199.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 4 | -121.5 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 8 | -147.4 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 12 | -166.7 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 16 | -181.7 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 20 | -178.1 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 24 | -191.1 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 28 | -194.0 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 32 | -183.7 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 36 | -203.6 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 40 | -192.1 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 44 | -189.3 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 48 | -194.9 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 52 | -196.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 56 | -200.9 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 60 | -198.0 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 68 | -201.7 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 72 | -203.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 76 | -202.1 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 80 | -202.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 84 | -202.9 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 88 | -205.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 92 | -202.2 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 96 | -199.0 microns |
| B: Faricimab 6 mg PTI | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 100 | -206.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 68 | -189.1 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 32 | -150.2 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 4 | -110.1 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 72 | -184.1 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 28 | -167.5 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 92 | -195.9 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 76 | -189.8 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 24 | -149.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 8 | -131.5 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 80 | -186.2 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 20 | -161.6 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 100 | -201.3 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 84 | -185.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 16 | -155.9 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 52 | -181.1 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 96 | -196.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 48 | -165.0 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 56 | -171.0 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 44 | -172.9 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 88 | -186.4 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 60 | -185.1 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 40 | -157.4 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 64 | -175.3 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 36 | -168.7 microns |
| C: Aflibercept 2 mg Q8W | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population | Week 12 | -147.4 microns |
Secondary
Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population
The NEI VFQ-25 captures a patient's perception of vision-related functioning and quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and one item on general health. The composite score ranges from 0 to 100, with higher scores, or a positive change from baseline, indicating better vision-related functioning. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% CI is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 24, 52, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 52 | 7.3 score on a scale |
| A: Faricimab 6 mg Q8W | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 24 | 6.0 score on a scale |
| A: Faricimab 6 mg Q8W | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 100 | 8.0 score on a scale |
| B: Faricimab 6 mg PTI | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 52 | 7.9 score on a scale |
| B: Faricimab 6 mg PTI | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 24 | 6.9 score on a scale |
| B: Faricimab 6 mg PTI | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 100 | 7.4 score on a scale |
| C: Aflibercept 2 mg Q8W | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 24 | 6.0 score on a scale |
| C: Aflibercept 2 mg Q8W | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 100 | 7.6 score on a scale |
| C: Aflibercept 2 mg Q8W | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population | Week 52 | 7.5 score on a scale |
Secondary
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 99.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 96.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 95.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 98.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 96.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 97.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 97.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 98.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 97.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 95.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 96.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 98.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 96.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 94.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 95.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 95.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 99.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 97.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 95.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 96.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 98.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 98.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 99.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 96.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 97.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 98.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 95.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 99.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 97.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 96.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 95.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 96.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 99.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 94.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 94.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 98.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 98.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 99.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 98.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 97.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 97.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 98.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 99.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 97.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 97.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 99.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 99.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 99.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 99.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 99.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 99.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 98.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 98.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 99.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 98.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 99.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 98.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 96.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 96.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 98.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 98.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 97.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 97.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 97.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 99.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 96.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 97.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 96.6 Percentage of participants |
Secondary
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 95.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 95.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 99.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 97.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 94.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 95.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 93.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 94.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 97.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 98.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 98.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 93.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 95.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 99.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 97.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 97.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 96.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 99.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 96.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 96.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 99.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 96.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 97.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 99.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 99.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 97.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 98.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 99.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 96.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 96.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 96.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 95.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 96.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 94.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 93.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 97.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 95.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 97.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 94.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 97.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 99.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 96.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 98.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 99.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 98.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 97.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 98.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 97.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 98.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 96.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 96.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 97.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 97.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 97.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 97.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 97.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 99.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 99.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 98.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 99.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 99.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 97.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 97.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 99.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 96.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 97.2 Percentage of participants |
Secondary
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, average of Weeks 48, 52, and 56
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥5 Letters | 95.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥10 Letters | 96.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥15 Letters | 98.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥5 Letters | 96.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥15 Letters | 98.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥10 Letters | 98.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥10 Letters | 98.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥15 Letters | 98.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Avoiding a Loss of ≥5 Letters | 96.3 Percentage of participants |
Comparison: This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-2.8, 1.3]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-2.2, 1.5]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-4.6, 0.9]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-2.2, 2.2]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-4.5, 2.2]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-2.6, 3.4]
Secondary
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, average of Weeks 48, 52, and 56
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥10 Letters | 96.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥15 Letters | 97.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥5 Letters | 95.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥15 Letters | 98.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥10 Letters | 97.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥5 Letters | 95.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥15 Letters | 99.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥5 Letters | 96.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Avoiding a Loss of ≥10 Letters | 98.6 Percentage of participants |
Comparison: This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-3.5, 1.3]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-3.1, 1.3]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-5.1, 0.9]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-3.5, 1.6]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-5.2, 2.8]
Comparison: This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-4.1, 3.3]
Secondary
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 99.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 97.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 99.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 96.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 97.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 97.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 99.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 97.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 97.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 97.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 99.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 96.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 100.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 99.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 99.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 98.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 99.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 98.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 97.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 99.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 98.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 99.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 98.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 98.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 98.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 99.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 99.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 96.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 98.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 99.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 98.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 97.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 99.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 98.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 97.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 98.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 96.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 97.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 98.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 97.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 99.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 99.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 99.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 99.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 99.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 98.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 98.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 98.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 98.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 99.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 99.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 97.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 98.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 97.8 Percentage of participants |
Secondary
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 98.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 99.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 96.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 99.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 99.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 96.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 99.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 96.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 96.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 99.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 96.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 100.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 99.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 95.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 96.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 97.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 96.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 99.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 98.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 98.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 98.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 97.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 96.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 99.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 98.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 97.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 97.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 97.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 97.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 98.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 97.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 97.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 96.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 99.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 99.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 100.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 99.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 98.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 97.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 97.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 98.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 99.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 97.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 99.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 98.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 99.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 99.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 99.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 98.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 98.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 99.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 100.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 97.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 99.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 99.5 Percentage of participants |
Secondary
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 94.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 89.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 96.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 94.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 96.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 95.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 93.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 98.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 95.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 93.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 96.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 96.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 94.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 97.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 94.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 92.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 97.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 96.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 96.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 91.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 94.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 92.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 96.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 95.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 96.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 96.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 96.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 97.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 94.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 96.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 93.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 95.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 92.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 92.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 97.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 92.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 88.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 97.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 98.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 97.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 95.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 95.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 96.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 98.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 96.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 95.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 96.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 98.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 96.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 97.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 96.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 94.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 96.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 97.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 98.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 98.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 96.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 96.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 97.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 97.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 97.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 95.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 96.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 94.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 95.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 97.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 96.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 96.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 94.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 95.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 97.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 94.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 96.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 95.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 97.3 Percentage of participants |
Secondary
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 94.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 94.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 95.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 98.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 94.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 97.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 96.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 90.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 97.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 92.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 96.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 88.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 91.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 96.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 97.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 94.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 92.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 95.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 96.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 95.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 97.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 91.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 92.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 94.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 98.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 96.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 99.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 98.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 96.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 96.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 95.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 95.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 97.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 98.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 97.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 96.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 97.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 95.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 95.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 94.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 95.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 96.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 95.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 93.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 92.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 96.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 91.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 92.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 91.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 88.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 95.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 95.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 96.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 96.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 93.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 96.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 94.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 98.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 94.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 94.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 97.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 97.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 94.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 98.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 98.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 96.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 96.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 98.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 96.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 97.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 96.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 96.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 94.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 97.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 96.9 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 89.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 93.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 92.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 88.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 90.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 92.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 88.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 87.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 91.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 90.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 91.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 95.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 89.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 89.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 91.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 91.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 87.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 86.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 90.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 89.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 92.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 89.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 92.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 87.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 93.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 91.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 94.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 94.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 94.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 91.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 90.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 91.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 94.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 93.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 93.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 95.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 93.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 94.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 93.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 93.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 93.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 92.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 92.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 91.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 91.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 92.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 90.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 91.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 88.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 86.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 91.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 91.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 89.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 92.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 90.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 93.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 91.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 92.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 88.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 90.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 89.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 90.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 92.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 93.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 91.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 91.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 93.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 90.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 91.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 92.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 92.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 90.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 89.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 92.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 91.5 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 86.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 91.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 94.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 94.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 92.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 93.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 91.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 91.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 95.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 89.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 91.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 89.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 92.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 92.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 88.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 86.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 89.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 87.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 85.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 88.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 90.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 87.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 91.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 93.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 90.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 90.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 90.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 87.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 93.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 92.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 96.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 90.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 92.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 94.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 93.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 89.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 92.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 94.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 92.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 93.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 92.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 94.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 86.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 93.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 88.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 93.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 90.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 93.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 93.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 91.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 91.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 93.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 90.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 91.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 90.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 91.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 92.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 90.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 91.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 89.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 91.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 92.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 90.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 93.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 92.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 90.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 94.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 91.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 92.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 89.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 92.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 92.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 92.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 89.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 89.4 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 60.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 60.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 55.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 43.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 64.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 55.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 63.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 56.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 59.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 61.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 55.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 61.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 35.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 55.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 60.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 23.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 55.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 59.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 63.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 57.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 64.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 45.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 59.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 63.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 30.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 31.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 62.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 37.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 62.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 47.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 61.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 60.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 67.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 61.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 48.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 64.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 59.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 53.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 59.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 58.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 57.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 58.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 60.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 65.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 58.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 60.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 60.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 60.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 63.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 59.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 61.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 59.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 64.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 62.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 66.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 27.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 46.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 49.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 50.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 48.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 57.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 53.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 55.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 53.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 57.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 41.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 60.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 59.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 60.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 59.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 56.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 64.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 60.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 64.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 62.7 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 63.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 61.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 67.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 59.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 31.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 64.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 36.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 60.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 62.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 55.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 63.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 61.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 57.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 66.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 25.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 55.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 55.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 64.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 57.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 44.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 60.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 59.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 58.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 65.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 43.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 60.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 46.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 47.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 53.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 57.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 59.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 59.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 58.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 58.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 62.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 59.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 60.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 62.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 66.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 62.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 65.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 65.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 62.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 32.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 37.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 56.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 59.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 66.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 63.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 60.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 61.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 63.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 58.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 61.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 54.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 61.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 29.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 62.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 43.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 55.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 53.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 49.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 57.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 51.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 66.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 49.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 62.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 56.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 48.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 67.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 60.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 59.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 60.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 64.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 65.0 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, average of Weeks 48, 52, and 56
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥15 Letters | 28.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥0 Letters | 91.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥5 Letters | 80.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥10 Letters | 57.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥0 Letters | 93.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥15 Letters | 35.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥10 Letters | 59.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥5 Letters | 77.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥15 Letters | 33.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥5 Letters | 84.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥0 Letters | 91.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population | Gaining ≥10 Letters | 57.5 Percentage of participants |
Comparison: This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-14, 3.5]
Comparison: This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-7, 10.3]
Comparison: This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-9.5, 9.5]
Comparison: This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-7.1, 11.3]
Comparison: This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-11.9, 2.9]
Comparison: This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-14.6, 0.2]
Comparison: This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-5.5, 5.2]
Comparison: This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-3, 7]
Secondary
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 20.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 37.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 29.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 40.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 7.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 29.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 39.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 37.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 31.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 25.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 34.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 31.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 41.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 38.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 40.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 26.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 14.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 39.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 23.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 13.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 36.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 28.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 39.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 34.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 24.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 41.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 13.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 18.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 23.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 27.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 28.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 34.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 31.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 36.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 40.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 37.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 37.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 39.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 37.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 38.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 41.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 43.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 38.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 44.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 42.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 41.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 39.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 41.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 40.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 40.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 37.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 25.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 11.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 35.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 29.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 38.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 37.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 25.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 16.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 36.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 24.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 40.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 38.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 22.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 36.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 38.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 31.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 34.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 35.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 35.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 34.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 30.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 34.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 32.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 22.1 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 32.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 21.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 39.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 27.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 33.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 27.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 27.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 40.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 23.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 21.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 27.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 37.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 35.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 14.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 39.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 26.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 37.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 42.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 8.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 40.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 37.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 30.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 37.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 15.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 41.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 45.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 30.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 37.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 35.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 43.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 14.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 19.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 22.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 28.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 27.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 34.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 37.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 41.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 39.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 39.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 38.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 42.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 43.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 39.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 45.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 43.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 40.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 42.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 41.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 42.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 34.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 38.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 38.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 12.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 33.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 41.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 36.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 32.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 39.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 40.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 37.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 41.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 29.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 27.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 40.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 34.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 26.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 24.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 36.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 37.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 24.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 37.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 36.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 17.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 40.1 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, average of Weeks 48, 52, and 56
Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 32.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 31.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 39.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 39.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 37.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 40.2 Percentage of participants |
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-12.6, 2.9]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-5.9, 9.8]
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-17.8, 0.5]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-9.9, 8.2]
Secondary
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 28.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 42.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 35.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 33.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 42.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 32.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 29.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 42.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 32.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 8.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 39.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 15.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 42.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 17.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 43.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 42.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 24.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 44.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 39.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 30.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 42.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 43.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 31.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 41.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 35.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 45.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 20.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 25.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 29.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 30.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 37.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 32.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 38.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 42.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 40.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 39.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 41.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 40.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 42.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 45.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 44.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 14.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 40.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 47.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 44.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 43.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 41.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 43.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 42.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 41.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 40.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 40.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 25.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 37.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 37.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 19.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 42.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 13.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 44.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 35.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 40.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 33.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 31.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 42.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 39.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 35.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 42.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 41.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 30.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 42.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 41.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 27.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 41.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 35.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 25.2 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 24.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 31.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 32.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 35.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 26.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 40.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 33.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 29.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 44.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 31.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 31.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 44.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 37.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 43.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 42.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 41.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 39.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 43.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 46.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 44.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 43.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 9.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 16.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 19.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 43.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 44.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 43.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 30.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 47.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 45.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 38.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 42.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 29.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 32.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 42.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 17.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 40.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 39.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 46.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 44.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 45.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 46.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 41.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 43.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 25.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 42.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 49.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 20.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 41.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 46.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 44.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 43.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 38.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 43.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 38.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 42.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 39.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 43.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 46.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 45.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 42.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 43.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 44.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 45.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 15.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 22.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 28.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 30.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 33.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 38.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 35.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 38.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 37.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 42.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 27.9 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 79.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 71.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 80.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 78.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 64.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 79.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 79.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 53.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 82.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 79.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 81.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 81.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 76.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 79.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 79.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 80.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 79.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 77.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 78.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 81.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 80.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 83.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 77.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 74.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 80.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 78.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 81.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 78.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 83.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 81.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 77.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 82.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 78.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 81.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 81.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 80.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 78.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 78.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 82.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 80.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 77.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 62.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 71.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 74.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 82.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 84.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 81.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 80.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 82.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 77.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 36 | 78.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 60 | 81.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 20 | 76.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 12 | 75.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 56 | 81.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 16 | 77.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 52 | 81.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 24 | 71.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 32 | 81.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 28 | 79.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 100 | 85.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 96 | 81.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 44 | 77.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 48 | 79.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 84 | 82.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 40 | 77.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 88 | 80.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 80 | 78.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 92 | 83.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 72 | 80.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 8 | 67.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 68 | 79.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 76 | 82.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 4 | 61.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population | Week 64 | 79.7 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 78.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 81.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 79.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 63.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 82.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 78.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 82.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 79.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 84.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 81.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 81.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 81.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 80.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 53.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 80.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 76.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 75.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 80.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 80.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 72.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 80.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 82.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 77.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 77.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 79.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 76.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 70.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 75.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 81.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 79.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 82.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 81.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 77.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 82.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 85.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 80.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 75.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 81.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 77.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 78.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 80.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 83.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 82.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 78.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 63.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 82.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 80.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 80.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 78.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 80.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 80.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 81.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 79.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 80.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 80.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 79.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 82.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 82.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 71.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 77.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 85.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 80.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 62.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 80.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 79.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 81.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 70.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 80.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 82.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 83.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 83.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 80.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 78.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 80.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 80.0 Percentage of participants |
Secondary
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, average of Weeks 48, 52, and 56
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥10 Letters | 57.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥0 Letters | 91.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥5 Letters | 78.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥15 Letters | 29.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥5 Letters | 79.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥0 Letters | 94.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥10 Letters | 58.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥15 Letters | 35.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥0 Letters | 91.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥15 Letters | 31.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥5 Letters | 81.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population | Gaining ≥10 Letters | 57.6 Percentage of participants |
Comparison: This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-10, 4.9]
Comparison: This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-4, 11.1]
Comparison: This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-8.6, 7.9]
Comparison: This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-7.4, 8.8]
Comparison: This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-9.1, 4.1]
Comparison: This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-8.5, 4.5]
Comparison: This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-4.6, 4.8]
Comparison: This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.95% CI: [-1, 7.5]
Secondary
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Time frame: From start of PTI (Week 12 or later) until Week 52
Population: ITT Population and Treatment-Naive Population. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations | ITT Population | 67.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations | Treatment-Naive Population | 71.6 Percentage of participants |
Secondary
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Time frame: From start of PTI (Week 12 or later) until Week 96
Population: ITT Population and Treatment-Naive Population. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations | ITT Population | 60.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations | Treatment-Naive Population | 64.4 Percentage of participants |
Secondary
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
Time frame: Week 52
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population | Once Every 4 Weeks | 10.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population | Once Every 8 Weeks | 15.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population | Once Every 12 Weeks | 21.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population | Once Every 16 Weeks | 52.8 Percentage of participants |
Secondary
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
Time frame: Week 52
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population | Once Every 4 Weeks | 9.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population | Once Every 8 Weeks | 14.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population | Once Every 12 Weeks | 22.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population | Once Every 16 Weeks | 54.5 Percentage of participants |
Secondary
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
Time frame: Week 96
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population | Once Every 4 Weeks | 7.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population | Once Every 8 Weeks | 14.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population | Once Every 12 Weeks | 18.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population | Once Every 16 Weeks | 60.0 Percentage of participants |
Secondary
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
Time frame: Week 96
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population | Once Every 4 Weeks | 7.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population | Once Every 8 Weeks | 11.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population | Once Every 12 Weeks | 16.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population | Once Every 16 Weeks | 64.9 Percentage of participants |
Secondary
Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period.
Time frame: Baseline, Weeks 4, 28, 52, 76, and 100
Population: The analysis population consisted of all participants receiving faricimab with at least one determinant post-baseline ADA assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Total Treatment-Emergent ADA-Positive | 12.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Treatment-Induced ADA-Positive | 12.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Treatment-Boosted ADA-Positive | 0.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Total Treatment-Emergent ADA-Positive | 10.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Treatment-Induced ADA-Positive | 10.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Treatment-Boosted ADA-Positive | 0.3 Percentage of participants |
Secondary
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 97.5% confidence interval (CI) is a rounding of 97.52% CI.
Time frame: Baseline and Week 52
Population: ITT Population and Treatment-Naive Population. Only participants with non-missing, valid assessments at Baseline and Week 52 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations | ITT Population | 46.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 49.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations | ITT Population | 42.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 47.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations | ITT Population | 35.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 42.5 Percentage of participants |
Comparison: The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.97.5% CI: [0.3, 20]
Comparison: The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.97.5% CI: [-3.6, 15.8]
Comparison: The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.p-value: 0.176197.5% CI: [-4.6, 18.9]Cochran-Mantel-Haenszel
Comparison: The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.p-value: 0.353997.5% CI: [-6.7, 16.3]Cochran-Mantel-Haenszel
Comparison: The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.p-value: 0.023797.5% CI: [0.3, 20]Cochran-Mantel-Haenszel
Comparison: The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.p-value: 0.167797.5% CI: [-3.6, 15.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 52, and 96
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 46.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 36.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 51.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 42.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 35.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 42.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 28.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 42.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 35.4 Percentage of participants |
Secondary
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 52, and 96
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 49.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 39.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 52.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 47.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 39.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 47.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 33.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 49.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 42.3 Percentage of participants |
Secondary
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 52, and 96
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 12.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 17.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 22.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 14.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 15.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 12.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 10.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 14.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 20.9 Percentage of participants |
Secondary
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 52, and 96
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 19.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 14.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 23.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 17.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 15.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 17.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 10.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 25.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 16.4 Percentage of participants |
Secondary
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 52, and 96
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 5.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 3.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 5.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 4.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 3.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 5.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 16 | 3.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 96 | 6.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population | Week 52 | 4.5 Percentage of participants |
Secondary
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 52, and 96
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 6.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 3.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 7.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 5.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 3.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 6.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 3.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 6.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 4.2 Percentage of participants |
Secondary
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Absence of diabetic macular edema was defined as achieving a central subfield thickness (CST) of \<325 microns in the study eye. CST was defined as the distance between the internal limiting membrane and Bruch's membrane. For each participant, an average CST value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Average of Weeks 48, 52, and 56
Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 81.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 83.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 78.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 80.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 65.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 68.3 Percentage of participants |
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [8.9, 23.1]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [5.4, 20]
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [7.3, 23.2]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [4.4, 20.6]
Secondary
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Absence of diabetic macular edema was defined as achieving a central subfield thickness of \<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 16 | 67.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 68 | 83.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 40 | 82.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 100 | 89.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 4 | 36.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 44 | 74.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 88 | 90.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 64 | 88.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 48 | 86.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 20 | 71.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 60 | 78.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 52 | 77.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 96 | 91.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 56 | 86.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 84 | 85.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 24 | 76.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 12 | 60.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 80 | 88.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 28 | 71.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 8 | 48.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 76 | 85.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 32 | 79.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 92 | 86.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 72 | 88.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 36 | 70.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 64 | 80.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 4 | 41.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 8 | 52.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 12 | 67.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 16 | 72.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 20 | 70.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 24 | 81.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 28 | 79.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 32 | 72.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 36 | 81.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 40 | 80.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 44 | 79.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 48 | 81.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 52 | 78.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 56 | 81.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 60 | 79.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 68 | 84.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 72 | 85.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 76 | 84.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 80 | 81.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 84 | 86.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 88 | 83.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 92 | 78.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 96 | 83.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 100 | 85.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 68 | 74.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 32 | 55.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 4 | 35.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 72 | 70.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 28 | 62.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 92 | 78.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 76 | 76.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 24 | 53.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 8 | 42.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 80 | 73.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 20 | 58.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 100 | 81.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 84 | 74.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 16 | 58.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 52 | 71.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 96 | 77.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 56 | 65.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 48 | 64.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 88 | 74.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 60 | 72.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 44 | 67.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 40 | 58.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 64 | 67.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 36 | 63.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population | Week 12 | 49.6 Percentage of participants |
Secondary
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 45.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 57.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 47.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 15.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 59.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 62.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 42.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 42.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 21.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 32.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 38.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 41.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 46.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 43.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 32.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 21.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 37.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 34.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 23.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 25.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 13.1 Percentage of participants |
Secondary
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 42.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 61.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 58.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 49.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 45.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 16.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 63.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 42.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 21.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 33.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 38.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 43.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 47.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 44.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 33.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 21.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 37.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 34.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 23.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 25.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 13.4 Percentage of participants |
Secondary
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 97.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 94.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 97.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 95.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 94.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 97.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 95.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 97.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 94.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 95.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 95.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 94.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 94.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 97.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 92 | 96.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 48 | 96.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 100 | 97.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 96 | 96.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 56 | 97.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 52 | 98.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population | Week 16 | 95.9 Percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Event
This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation.
Time frame: From first dose of study drug through end of study (up to 2 years)
Population: The safety-evaluable population comprised all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Adverse Event | AE of Special Interest (AESI) | 6.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Adverse Event | Adverse Event (AE) | 92.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Adverse Event | AE Leading to Withdrawal from Study Treatment | 2.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Adverse Event | Serious AE (SAE) | 35.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Adverse Event | AE Leading to Withdrawal from Study Treatment | 2.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Adverse Event | AE of Special Interest (AESI) | 7.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Adverse Event | Serious AE (SAE) | 37.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Adverse Event | Adverse Event (AE) | 91.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Adverse Event | AE of Special Interest (AESI) | 4.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Adverse Event | Serious AE (SAE) | 29.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Adverse Event | AE Leading to Withdrawal from Study Treatment | 1.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Adverse Event | Adverse Event (AE) | 89.1 Percentage of participants |
Secondary
Percentage of Participants With at Least One Non-Ocular Adverse Event
This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
Time frame: From first dose of study drug through end of study (up to 2 years)
Population: The safety-evaluable population comprised all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE of Special Interest (AESI) | 0.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE Leading to Withdrawal from Study Treatment | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | Adverse Event (AE) | 76.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | Serious AE (SAE) | 31.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | AESI, Elevated ALT or AST with Either Elevated Bilirubin or Clinical Jaundice | 0.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE Leading to Withdrawal from Study Treatment | 1.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Non-Ocular Adverse Event | Adverse Event (AE) | 80.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Non-Ocular Adverse Event | Serious AE (SAE) | 31.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE of Special Interest (AESI) | 0.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Non-Ocular Adverse Event | AESI, Elevated ALT or AST with Either Elevated Bilirubin or Clinical Jaundice | 0.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | AESI, Elevated ALT or AST with Either Elevated Bilirubin or Clinical Jaundice | 0.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE of Special Interest (AESI) | 0.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | Adverse Event (AE) | 77.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE Leading to Withdrawal from Study Treatment | 1.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Non-Ocular Adverse Event | Serious AE (SAE) | 27.0 Percentage of participants |
Secondary
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
This analysis of adverse events (AEs) only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation.
Time frame: From first dose of study drug through end of study (up to 2 years)
Population: The safety-evaluable population comprised all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AE of Special Interest (AESI) | 3.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AE Leading to Withdrawal from Treatment | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: SAE | 2.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Drop in VA Score ≥30 Letters | 2.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Serious AE (SAE) | 3.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AE | 40.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Associated with Severe IOI | 0.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Drop in VA Score ≥30 Letters | 2.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss | 1.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related AE | 3.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss | 1.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Adverse Event (AE) | 47.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related SAE | 0.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Associated with Severe IOI | 0.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI | 2.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI | 2.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Adverse Event (AE) | 46.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Serious AE (SAE) | 4.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AE Leading to Withdrawal from Treatment | 1.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related AE | 2.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related SAE | 1.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AE of Special Interest (AESI) | 4.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Drop in VA Score ≥30 Letters | 2.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Associated with Severe IOI | 1.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss | 1.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AE | 42.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: SAE | 3.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Drop in VA Score ≥30 Letters | 1.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Associated with Severe IOI | 0.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss | 1.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AE of Special Interest (AESI) | 2.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Associated with Severe IOI | 0.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: SAE | 2.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related SAE | 0.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related AE | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI | 2.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AE Leading to Withdrawal from Treatment | 0.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Adverse Event (AE) | 46.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Drop in VA Score ≥30 Letters | 1.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Associated with Severe IOI | 0.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Serious AE (SAE) | 2.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss | 0.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: AESI, Drop in VA Score ≥30 Letters | 2.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss | 1.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AE | 46.3 Percentage of participants |
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, average of Weeks 48, 52, and 56
Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 2.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 2.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 1.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 1.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 1.8 Percentage of participants |
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-1.8, 2.9]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-2.2, 2.3]
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-2, 3.6]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-2.6, 2.5]
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement invisual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 1.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 0.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 1.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 1.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 1.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 1.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 1.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 1.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 1.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 3.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 2.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 1.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 1.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 0.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 2.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 0.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 0.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 2.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 1.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 2.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 0.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 1.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 1.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 1.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 2.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 2.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 3.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 2.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 2.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 1.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 1.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 1.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 1.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 1.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 2.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 1.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 2.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 1.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 1.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 2.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 2.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 1.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 2.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 1.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 1.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 2.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 2.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 1.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 1.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 1.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 1.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 2.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 1.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 1.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 3.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 1.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 3.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 2.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 0.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 1.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 1.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 1.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 1.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 1.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 2.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 1.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 1.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 1.8 Percentage of participants |
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 1.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 1.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 0.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 1.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 2.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 1.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 1.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 1.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 1.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 2.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 1.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 1.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 1.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 1.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 1.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 2.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 2.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 2.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 1.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 1.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 0.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 1.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 2.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 2.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 2.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 1.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 2.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 2.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 3.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 2.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 2.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 1.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 1.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 1.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 1.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 1.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 2.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 2.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 2.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 1.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 1.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 1.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 1.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 1.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 1.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 2.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 1.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 1.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 3.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 1.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 2.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 2.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 1.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 1.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 3.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 0.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 2.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 1.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 1.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 1.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 2.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 1.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 1.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 1.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 1.7 Percentage of participants |
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Baseline, average of Weeks 48, 52, and 56
Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 71.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 72.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 77.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 75.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | ITT Population | 74.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations | Treatment-Naive Population | 77.4 Percentage of participants |
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-10.2, 3.8]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-4.3, 9.2]
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-12.6, 3.1]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-8.9, 6.4]
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 72.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 60.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 64.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 66.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 70.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 71.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 71.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 71.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 71.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 69.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 70.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 73.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 69.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 74.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 71.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 74.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 74.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 73.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 53.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 74.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 73.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 72.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 75.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 75.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 75.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 74.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 77.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 74.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 79.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 78.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 75.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 77.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 77.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 78.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 76.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 77.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 79.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 76.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 70.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 76.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 76.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 60.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 78.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 65.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 69.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 70.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 76.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 69.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 76.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 74.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 88 | 73.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 4 | 57.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 44 | 73.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 32 | 74.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 76 | 76.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 60 | 75.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 36 | 73.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 72 | 71.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 96 | 73.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 40 | 73.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 100 | 75.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 16 | 74.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 80 | 73.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 28 | 75.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 48 | 72.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 92 | 77.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 24 | 71.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 52 | 75.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 8 | 66.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 68 | 73.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 56 | 72.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 84 | 77.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 20 | 70.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 12 | 68.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population | Week 64 | 71.4 Percentage of participants |
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 66.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 73.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 55.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 62.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 68.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 72.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 73.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 71.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 74.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 70.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 71.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 74.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 71.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 76.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 73.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 77.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 77.6 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 76.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 72.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 76.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 75.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 71.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 75.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 77.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 77.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 73.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 73.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 72.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 70.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 79.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 76.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 74.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 76.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 75.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 75.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 77.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 74.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 77.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 75.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 75.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 75.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 77.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 77.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 60.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 75.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 66.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 69.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 68.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 67.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 74.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 88 | 76.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 68 | 75.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 28 | 77.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 76 | 78.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 36 | 73.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 32 | 75.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 40 | 75.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 44 | 76.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 56 | 74.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 60 | 78.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 80 | 76.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 12 | 70.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 72 | 74.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 100 | 77.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 48 | 75.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 20 | 72.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 4 | 60.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 52 | 77.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 84 | 77.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 16 | 75.8 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 96 | 75.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 92 | 79.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 8 | 69.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 24 | 72.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population | Week 64 | 74.4 Percentage of participants |
Secondary
Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced PDR. High-risk PDR was defined as an ETDRS DRSS score of ≥71 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.
Time frame: Baseline and Week 52
Population: ITT Population and Treatment-Naive Population. Only participants with non-missing, valid assessments at Baseline and Week 52 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations | ITT Population | 0.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 0.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations | ITT Population | 0.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 0.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations | ITT Population | 0.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 0.0 Percentage of participants |
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-0.4, 1.2]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [0, 0]
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [0, 0]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [0, 0]
Secondary
Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). PDR was defined as an ETDRS DRSS score of ≥61 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted percentages of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.
Time frame: Baseline and Week 52
Population: ITT Population and Treatment-Naive Population. Only participants with non-missing, valid assessments at Baseline and Week 52 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations | ITT Population | 0.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 0.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations | ITT Population | 0.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 1.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations | ITT Population | 0.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations | Treatment-Naive Population | 0.6 Percentage of participants |
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-1.1, 2]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.95% CI: [-1.1, 2]
Comparison: This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-1.9, 0.6]
Comparison: This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.95% CI: [-1.5, 2.5]
Secondary
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Retinal dryness was defined as achieving a central subfield thickness (ILM-BM) of \<280 microns. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 16 | 38.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 68 | 61.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 40 | 57.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 100 | 71.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 4 | 15.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 44 | 51.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 88 | 72.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 64 | 68.5 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 48 | 63.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 20 | 45.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 60 | 60.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 52 | 57.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 96 | 72.7 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 56 | 66.3 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 84 | 67.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 24 | 53.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 12 | 32.4 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 80 | 70.1 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 28 | 45.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 8 | 24.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 76 | 65.9 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 32 | 55.0 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 92 | 66.2 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 72 | 65.8 Percentage of participants |
| A: Faricimab 6 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 36 | 48.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 64 | 55.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 4 | 16.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 8 | 24.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 12 | 34.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 16 | 42.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 20 | 40.6 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 24 | 48.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 28 | 50.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 32 | 43.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 36 | 54.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 40 | 51.3 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 44 | 51.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 48 | 50.1 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 52 | 54.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 56 | 56.9 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 60 | 54.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 68 | 57.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 72 | 58.5 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 76 | 54.8 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 80 | 54.7 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 84 | 61.2 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 88 | 58.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 92 | 58.0 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 96 | 61.4 Percentage of participants |
| B: Faricimab 6 mg PTI | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 100 | 60.5 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 68 | 52.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 32 | 30.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 4 | 12.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 72 | 47.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 28 | 34.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 92 | 57.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 76 | 53.9 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 24 | 26.6 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 8 | 16.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 80 | 51.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 20 | 29.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 100 | 60.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 84 | 56.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 16 | 23.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 52 | 42.3 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 96 | 58.0 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 56 | 41.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 48 | 36.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 88 | 54.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 60 | 47.7 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 44 | 37.1 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 40 | 32.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 64 | 47.4 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 36 | 39.2 Percentage of participants |
| C: Aflibercept 2 mg Q8W | Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population | Week 12 | 22.1 Percentage of participants |
Secondary
Plasma Concentration of Faricimab Over Time
Faricimab concentration in plasma was determined using a validated immunoassay method.
Time frame: Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100
Population: This analysis only included participants in Arms A and B who received treatment with faricimab and with at least one plasma sample, provided sufficient dosing information (dose and dosing time) was available. The number of participants analyzed at a given timepoint includes those with an available plasma sample and dosing information at that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: Faricimab 6 mg Q8W | Plasma Concentration of Faricimab Over Time | Week 4 | 0.0211 micrograms per millilitre (μg/mL) | Standard Deviation 0.0337 |
| A: Faricimab 6 mg Q8W | Plasma Concentration of Faricimab Over Time | Baseline | 0.0000 micrograms per millilitre (μg/mL) | Standard Deviation 0.0001 |
| A: Faricimab 6 mg Q8W | Plasma Concentration of Faricimab Over Time | Week 28 | 0.0033 micrograms per millilitre (μg/mL) | Standard Deviation 0.0053 |
| A: Faricimab 6 mg Q8W | Plasma Concentration of Faricimab Over Time | Week 52 | 0.0052 micrograms per millilitre (μg/mL) | Standard Deviation 0.0104 |
| A: Faricimab 6 mg Q8W | Plasma Concentration of Faricimab Over Time | Week 76 | 0.0048 micrograms per millilitre (μg/mL) | Standard Deviation 0.0085 |
| A: Faricimab 6 mg Q8W | Plasma Concentration of Faricimab Over Time | Week 100 | 0.0052 micrograms per millilitre (μg/mL) | Standard Deviation 0.0087 |
| B: Faricimab 6 mg PTI | Plasma Concentration of Faricimab Over Time | Week 76 | 0.0068 micrograms per millilitre (μg/mL) | Standard Deviation 0.0255 |
| B: Faricimab 6 mg PTI | Plasma Concentration of Faricimab Over Time | Week 4 | 0.0181 micrograms per millilitre (μg/mL) | Standard Deviation 0.0139 |
| B: Faricimab 6 mg PTI | Plasma Concentration of Faricimab Over Time | Baseline | 0.0000 micrograms per millilitre (μg/mL) | Standard Deviation 0.0001 |
| B: Faricimab 6 mg PTI | Plasma Concentration of Faricimab Over Time | Week 52 | 0.0100 micrograms per millilitre (μg/mL) | Standard Deviation 0.0132 |
| B: Faricimab 6 mg PTI | Plasma Concentration of Faricimab Over Time | Week 100 | 0.0077 micrograms per millilitre (μg/mL) | Standard Deviation 0.0126 |
| B: Faricimab 6 mg PTI | Plasma Concentration of Faricimab Over Time | Week 28 | 0.0089 micrograms per millilitre (μg/mL) | Standard Deviation 0.0145 |