Wet Macular Degeneration
Conditions
Keywords
AMD, nAMD, neovascular age-related macular degeneration, choroidal neovascularization secondary to age-related macular degeneration
Brief summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
Interventions
PROCEDURESham Procedure
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
DRUGFaricimab
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
DRUGAflibercept
Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
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
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye * Ability to comply with the study protocol, in the investigator's judgment * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment * Other protocol-specified inclusion criteria may apply
Exclusion criteria
* Uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while a patient is at rest on Day 1 * Pregnancy or breastfeeding, or intention to become pregnant during the study * CNV due to causes other than AMD in the study eye * Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye * Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study * Uncontrolled glaucoma in the study eye * Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye * Prior IVT administration of faricimab in either eye * History of idiopathic or autoimmune-associated uveitis in either eye * Active ocular inflammation or suspected or active ocular or periocular infection in either eye * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | From Baseline through Week 48 | 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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after 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% CI is a rounding of 95.03% CI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after 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% CI is a rounding of 95.03% CI. |
| Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Baseline, average of Weeks 40, 44, and 48 | 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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | Baseline, average of Weeks 52, 56, and 60 | 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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Baseline, average of Weeks 40, 44, and 48 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | Baseline, average of Weeks 52, 56, and 60 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | Baseline, average of Weeks 40, 44, and 48 | 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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | Baseline, average of Weeks 40, 44, and 48 | 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 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 letters vs. ≥69 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | Baseline, average of Weeks 40, 44, and 48 | 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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | 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, 100, 104, 108, and 112 | 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI. |
| Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48 | Week 48 | Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 48. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI. |
| Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60 | Week 60 | Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 60. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI. |
| Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112 | Weeks 108 and 112 | Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 112. Treatment interval at a given visit is defined as the treatment interval decision followed at that visit. Treatment interval at Week 112 is calculated using data recorded at Week 108. The 95% confidence interval (CI) is a rounding of 95.03% CI. |
| Number of Study Drug Injections Received in the Study Eye Through Week 48 | From Baseline through Week 48 | — |
| Number of Study Drug Injections Received in the Study Eye Through Week 60 | From Baseline through Week 60 | — |
| Number of Study Drug Injections Received in the Study Eye Through Week 108 | From Baseline through Week 108 | — |
| Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48 | From Baseline through Week 48 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI. |
| Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60 | From Baseline through Week 60 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI. |
| Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | 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, 100, 104, 108, and 112 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI. |
| Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 | Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre \[mm\]). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI. |
| Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112 | Baseline and Week 112 | The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization. |
| Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 | Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI. |
| Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 | Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre \[mm\]). The weighted estimates of the percentage of participants with absence of intraretinal and subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI. |
| Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 | Pigment epithelial detachment was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of pigment epithelial detachment were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI. |
| Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time | Up to 112 weeks | — |
| Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48 | Baseline and Week 48 | The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization. |
| Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48 | Baseline and Week 48 | The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization. |
| Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112 | Baseline and Week 112 | The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization. |
| Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | From Baseline through Week 60 | 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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after 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% CI is a rounding of 95.03% CI. |
| 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 112 weeks) | 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. Multiple occurrences of the same AE in one individual are counted only once. 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 (IOI). |
| Percentage of Participants With at Least One Non-Ocular Adverse Event | From first dose of study drug through end of study (up to 112 weeks) | This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. 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. 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 at Baseline, Weeks 4, 16, 20, 48, 76, and 112 | Faricimab concentration in plasma was determined using a validated immunoassay method. |
| Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112 | 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 at Least One Adverse Event | From first dose of study drug through end of study (up to 112 weeks) | This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. 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 (IOI). |
Countries
Canada, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
A total of 989 patients were screened, 318 of whom failed screening most commonly due to not meeting inclusion criteria. A total of 671 treatment-naive patients with nAMD were randomized 1:1 into the study: 334 to the faricimab arm and 337 to the aflibercept arm.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Faricimab Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W). | 334 |
| Arm B: Aflibercept Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104). | 337 |
| Total | 671 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 8 |
| Overall Study | Death | 13 | 7 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Lost to Follow-up | 7 | 8 |
| Overall Study | Other | 2 | 4 |
| Overall Study | Physician Decision | 5 | 2 |
| Overall Study | Withdrawal by Subject | 25 | 17 |
Baseline characteristics
| Characteristic | Total | Arm B: Aflibercept | Arm A: Faricimab |
|---|---|---|---|
| Age, Continuous | 76.3 Years STANDARD_DEVIATION 8.7 | 76.7 Years STANDARD_DEVIATION 8.8 | 75.9 Years STANDARD_DEVIATION 8.6 |
| Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye | 61.4 ETDRS Letters STANDARD_DEVIATION 12.7 | 61.5 ETDRS Letters STANDARD_DEVIATION 12.9 | 61.3 ETDRS Letters STANDARD_DEVIATION 12.5 |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography Classic | 157 Participants | 73 Participants | 84 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography Minimally Classic | 62 Participants | 30 Participants | 32 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography Missing | 12 Participants | 8 Participants | 4 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography Occult | 351 Participants | 174 Participants | 177 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography Polypoidal Choroidal Vasculopathy (PCV) | 12 Participants | 6 Participants | 6 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography Predominantly Classic | 36 Participants | 19 Participants | 17 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography Retinal Angiomatous Proliferation (RAP) | 41 Participants | 27 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants | 26 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 611 Participants | 308 Participants | 303 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 3 Participants | 5 Participants |
| Number of Participants by the BCVA Letter Score Categories in the Study Eye ≤54 Letters | 171 Participants | 84 Participants | 87 Participants |
| Number of Participants by the BCVA Letter Score Categories in the Study Eye 73 to 55 Letters | 401 Participants | 201 Participants | 200 Participants |
| Number of Participants by the BCVA Letter Score Categories in the Study Eye ≥74 Letters | 99 Participants | 52 Participants | 47 Participants |
| Number of Participants by the Eye (Right or Left) Chosen as the Study Eye Left Eye | 327 Participants | 159 Participants | 168 Participants |
| Number of Participants by the Eye (Right or Left) Chosen as the Study Eye Right Eye | 344 Participants | 178 Participants | 166 Participants |
| Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye <33 Letters | 471 Participants | 235 Participants | 236 Participants |
| Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye ≥33 Letters | 193 Participants | 98 Participants | 95 Participants |
| Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye Missing/Invalid | 7 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 54 Participants | 28 Participants | 26 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 605 Participants | 302 Participants | 303 Participants |
| Region of Enrollment Asia | 52 Participants | 26 Participants | 26 Participants |
| Region of Enrollment Rest of the World | 253 Participants | 127 Participants | 126 Participants |
| Region of Enrollment United States and Canada | 366 Participants | 184 Participants | 182 Participants |
| Sex: Female, Male Female | 402 Participants | 211 Participants | 191 Participants |
| Sex: Female, Male Male | 269 Participants | 126 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 333 | 7 / 336 |
| other Total, other adverse events | 211 / 333 | 200 / 336 |
| serious Total, serious adverse events | 80 / 333 | 93 / 336 |
Outcome results
Primary
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after 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% CI is a rounding of 95.03% CI.
Time frame: From Baseline through Week 48
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | 5.8 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | 5.1 ETDRS Letters |
Comparison: The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.95% CI: [-1.1, 2.5]
Secondary
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after 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% CI is a rounding of 95.03% CI.
Time frame: From Baseline through Week 60
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | 5.4 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | 4.6 ETDRS Letters |
Comparison: Treatment Difference in Adjusted Means at Weeks 52-6095% CI: [-1.2, 2.7]
Secondary
Change From Baseline in BCVA in the Study Eye Over Time
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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after 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% CI is a rounding of 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 16 | 6.8 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 60 | 4.9 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 32 | 6.2 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 64 | 5.5 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 92 | 4.2 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 36 | 6.5 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 68 | 5.3 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 20 | 6.6 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 72 | 4.8 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 40 | 6.1 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 76 | 4.7 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 12 | 6.4 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 80 | 4.6 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 44 | 5.8 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 84 | 4.5 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 24 | 6.4 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 88 | 4.3 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 8 | 5.5 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 96 | 4.2 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 48 | 5.5 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 100 | 4.3 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 28 | 6.2 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 104 | 4.1 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 52 | 5.6 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 108 | 3.6 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 56 | 5.5 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 112 | 3.5 ETDRS Letters |
| Arm A: Faricimab | Change From Baseline in BCVA in the Study Eye Over Time | Week 4 | 4.0 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 112 | 3.1 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 4 | 3.6 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 8 | 4.5 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 12 | 5.3 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 16 | 5.2 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 20 | 4.9 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 24 | 5.1 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 28 | 5.6 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 32 | 5.1 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 36 | 5.5 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 40 | 5.1 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 52 | 4.5 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 44 | 5.1 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 48 | 5.2 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 56 | 4.7 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 60 | 4.7 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 88 | 3.7 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 64 | 4.8 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 68 | 4.6 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 72 | 4.0 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 76 | 4.4 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 80 | 3.5 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 84 | 3.5 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 92 | 3.7 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 96 | 3.7 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 100 | 3.6 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 104 | 3.6 ETDRS Letters |
| Arm B: Aflibercept | Change From Baseline in BCVA in the Study Eye Over Time | Week 108 | 3.2 ETDRS Letters |
Secondary
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI.
Time frame: From Baseline through Week 48
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48 | -136.8 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48 | -129.4 microns |
Comparison: Treatment Difference in Adjusted Means at Weeks 40-4895% CI: [-15.7, 0.8]
Secondary
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI.
Time frame: From Baseline through Week 60
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60 | -134.5 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60 | -135.5 microns |
Comparison: Treatment Difference in Adjusted Means at Weeks 52-6095% CI: [-7.4, 9.4]
Secondary
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 60 | -124.1 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 20 | -132.9 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 64 | -145.4 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 36 | -132.8 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 68 | -137.5 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 8 | -142.6 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 72 | -139.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 40 | -140.8 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 76 | -135.3 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 24 | -128.8 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 80 | -146.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 44 | -133.9 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 84 | -141.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 16 | -148.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 88 | -143.9 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 48 | -138.1 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 92 | -144.8 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 28 | -129.1 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 96 | -147.6 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 52 | -139.9 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 100 | -145.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 12 | -149.0 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 104 | -147.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 56 | -140.4 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 108 | -141.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 32 | -142.7 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 112 | -150.1 microns |
| Arm A: Faricimab | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 4 | -131.7 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 112 | -144.3 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 4 | -116.3 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 8 | -131.8 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 12 | -136.1 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 16 | -110.4 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 20 | -136.1 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 24 | -115.5 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 28 | -132.5 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 32 | -114.5 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 36 | -139.1 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 40 | -123.9 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 44 | -142.4 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 48 | -126.0 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 52 | -139.6 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 56 | -125.9 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 60 | -143.5 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 64 | -127.8 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 68 | -142.8 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 72 | -132.0 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 76 | -142.8 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 80 | -132.1 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 84 | -143.2 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 88 | -139.3 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 92 | -148.5 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 96 | -139.7 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 100 | -147.1 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 104 | -143.4 microns |
| Arm B: Aflibercept | Change From Baseline in Central Subfield Thickness in the Study Eye Over Time | Week 108 | -151.0 microns |
Secondary
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112
The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time frame: Baseline and Week 112
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 Week 112 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Faricimab | Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112 | -5.4 millimetres squared (mm^2) | Standard Deviation 5.7 |
| Arm B: Aflibercept | Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112 | -5.0 millimetres squared (mm^2) | Standard Deviation 6.4 |
Secondary
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48
The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time frame: Baseline and Week 48
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 Week 48 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Faricimab | Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48 | -3.8 millimetres squared (mm^2) | Standard Deviation 6.9 |
| Arm B: Aflibercept | Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48 | -3.0 millimetres squared (mm^2) | Standard Deviation 6.9 |
Secondary
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112
The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time frame: Baseline and Week 112
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 Week 112 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Faricimab | Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112 | 1.2 millimetres squared (mm^2) | Standard Deviation 4.6 |
| Arm B: Aflibercept | Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112 | 1.6 millimetres squared (mm^2) | Standard Deviation 5 |
Secondary
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48
The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time frame: Baseline and Week 48
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 Week 48 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Faricimab | Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48 | 0.0 millimetres squared (mm^2) | Standard Deviation 4.5 |
| Arm B: Aflibercept | Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48 | 0.4 millimetres squared (mm^2) | Standard Deviation 4.8 |
Secondary
Number of Study Drug Injections Received in the Study Eye Through Week 108
Time frame: From Baseline through Week 108
Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Faricimab | Number of Study Drug Injections Received in the Study Eye Through Week 108 | 10.0 Injections |
| Arm B: Aflibercept | Number of Study Drug Injections Received in the Study Eye Through Week 108 | 15.0 Injections |
Secondary
Number of Study Drug Injections Received in the Study Eye Through Week 48
Time frame: From Baseline through Week 48
Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Faricimab | Number of Study Drug Injections Received in the Study Eye Through Week 48 | 6.0 Injections |
| Arm B: Aflibercept | Number of Study Drug Injections Received in the Study Eye Through Week 48 | 8.0 Injections |
Secondary
Number of Study Drug Injections Received in the Study Eye Through Week 60
Time frame: From Baseline through Week 60
Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Faricimab | Number of Study Drug Injections Received in the Study Eye Through Week 60 | 7.0 Injections |
| Arm B: Aflibercept | Number of Study Drug Injections Received in the Study Eye Through Week 60 | 9.0 Injections |
Secondary
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
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 percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 91.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 90.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 85.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 95.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 96.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 96.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 95.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 93.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 94.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 93.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 92.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 93.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 92.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 92.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 91.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 92.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 91.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 92.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 89.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 89.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 89.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 89.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 89.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 87.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 87.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 88.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 87.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 84.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 86.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 90.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 88.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 85.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 96.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 90.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 96.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 84.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 95.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 90.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 92.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 86.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 92.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 88.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 94.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 85.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 94.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 88.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 92.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 85.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 91.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 86.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 91.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 87.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 90.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 86.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 91.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 91.1 Percentage of participants |
Secondary
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI.
Time frame: Baseline, average of Weeks 40, 44, and 48
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Avoiding a Loss of ≥15 Letters | 95.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Avoiding a Loss of ≥10 Letters | 91.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Avoiding a Loss of ≥5 Letters | 88.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Avoiding a Loss of ≥15 Letters | 94.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Avoiding a Loss of ≥10 Letters | 92.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Avoiding a Loss of ≥5 Letters | 86.8 Percentage of participants |
Comparison: Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-4895% CI: [-2.2, 4.8]
Comparison: Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-4895% CI: [-4.6, 3.9]
Comparison: Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-4895% CI: [-4, 6.4]
Secondary
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI.
Time frame: Baseline, average of Weeks 52, 56, and 60
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60 were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | 93.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | 94.1 Percentage of participants |
Comparison: Treatment Difference in CMH Weighted Percentages at Weeks 52-6095% CI: [-3.9, 3.6]
Secondary
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
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 percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 93.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 97.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 97.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 98.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 98.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 97.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 97.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 95.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 95.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 95.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 96.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 95.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 94.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 93.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 94.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 93.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 94.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 92.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 93.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 94.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 93.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 92.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 93.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 92.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 91.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 92.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 92.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 90.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 95.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 89.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 99.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 92.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 98.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 90.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 97.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 92.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 97.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 90.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 94.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 92.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 97.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 93.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 96.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 91.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 95.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 88.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 95.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 92.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 94.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 88.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 93.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 90.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 93.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 89.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 93.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 91.5 Percentage of participants |
Secondary
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
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 percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 81.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 89.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 87.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 88.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 85.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 92.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 84.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 86.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 83.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 89.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 81.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 85.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 82.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 90.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 80.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 85.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 81.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 88.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 82.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 84.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 81.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 92.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 79.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 84.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 79.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 87.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 78.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 90.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 78.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 90.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 90.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 88.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 87.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 87.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 88.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 90.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 85.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 86.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 87.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 85.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 83.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 85.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 83.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 84.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 85.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 87.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 81.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 83.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 81.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 81.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 78.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 79.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 78.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 80.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 80.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 80.7 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 77.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 78.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 76.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 81.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 74.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 75.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 77.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 77.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 74.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 80.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 74.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 78.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 75.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 73.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 75.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 78.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 75.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 77.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 74.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 77.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 84.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 74.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 77.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 74.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 73.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 80.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 72.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 84.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 70.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 71.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 77.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 78.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 81.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 78.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 79.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 79.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 82.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 76.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 81.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 80.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 78.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 76.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 75.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 78.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 77.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 73.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 77.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 74.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 72.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 74.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 72.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 71.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 70.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 71.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 69.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 73.7 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 36.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 40.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 38.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 37.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 20.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 40.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 37.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 40.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 39.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 39.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 35.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 36.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 38.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 31.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 38.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 39.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 37.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 41.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 39.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 36.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 38.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 28.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 38.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 38.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 35.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 38.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 39.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 40.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 34.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 16.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 25.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 30.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 31.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 30.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 34.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 34.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 32.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 34.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 33.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 34.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 36.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 37.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 36.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 34.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 36.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 33.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 34.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 33.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 34.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 33.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 35.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 35.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 36.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 38.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 36.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 33.5 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI.
Time frame: Baseline, average of Weeks 52, 56, and 60
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60 were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | 19.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 | 16.6 Percentage of participants |
Comparison: Treatment Difference in CMH Weighted Percentages at Weeks 52-6095% CI: [-3.2, 8.5]
Secondary
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 21.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 19.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 20.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 21.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 23.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 10.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 21.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 22.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 22.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 22.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 19.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 22.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 21.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 17.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 24.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 21.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 21.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 20.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 23.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 22.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 21.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 16.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 22.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 23.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 21.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 21.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 24.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 13.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 19.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 6.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 8.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 10.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 13.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 12.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 13.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 16.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 15.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 15.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 15.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 17.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 19.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 18.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 18.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 17.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 20.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 18.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 17.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 18.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 18.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 18.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 18.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 19.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 20.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 18.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 18.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 19.0 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI.
Time frame: Baseline, average of Weeks 40, 44, and 48
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | 24.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | 21.3 Percentage of participants |
Comparison: Treatment Difference in CMH Weighted Percentages at Weeks 40-4895% CI: [-3.6, 9.5]
Secondary
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 60 | 25.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 20 | 22.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 64 | 24.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 36 | 27.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 68 | 27.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 8 | 16.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 72 | 26.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 40 | 26.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 76 | 27.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 24 | 25.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 80 | 24.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 44 | 26.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 84 | 26.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 16 | 20.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 88 | 29.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 48 | 24.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 92 | 27.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 28 | 25.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 96 | 28.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 52 | 25.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 100 | 27.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 12 | 20.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 104 | 27.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 56 | 26.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 108 | 27.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 32 | 27.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 112 | 26.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 4 | 11.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 112 | 25.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 4 | 8.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 8 | 11.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 12 | 14.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 16 | 17.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 20 | 17.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 24 | 19.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 28 | 20.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 32 | 21.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 36 | 23.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 40 | 21.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 44 | 22.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 48 | 27.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 52 | 23.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 56 | 24.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 60 | 22.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 64 | 25.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 68 | 24.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 72 | 24.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 76 | 23.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 80 | 25.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 84 | 23.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 88 | 25.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 92 | 27.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 96 | 26.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 100 | 24.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 104 | 23.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time | Week 108 | 24.2 Percentage of participants |
Secondary
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 53.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 59.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 60.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 60.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 59.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 60.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 59.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 61.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 55.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 59.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 58.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 60.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 59.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 62.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 57.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 63.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 47.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 58.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 57.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 61.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 56.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 60.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 58.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 60.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 59.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 60.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 59.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 59.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 104 | 54.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 108 | 54.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 12 | 55.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 16 | 54.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 20 | 55.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 24 | 53.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 28 | 61.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 32 | 56.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 36 | 58.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 40 | 54.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 44 | 59.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 48 | 58.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 52 | 58.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 56 | 54.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 60 | 57.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 64 | 55.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 68 | 57.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 72 | 52.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 76 | 55.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 80 | 55.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 84 | 55.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 88 | 53.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 112 | 53.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 4 | 45.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 92 | 56.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 96 | 57.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 100 | 57.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time | Week 8 | 52.3 Percentage of participants |
Secondary
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI.
Time frame: Baseline, average of Weeks 40, 44, and 48
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥15 Letters | 20.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥10 Letters | 37.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥5 Letters | 59.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥0 Letters | 75.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥0 Letters | 76.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥15 Letters | 15.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥5 Letters | 58.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 | Gaining ≥10 Letters | 31.7 Percentage of participants |
Comparison: Gaining ≥15 Letters: Treatment Difference at Weeks 40-4895% CI: [-1.6, 10.1]
Comparison: Gaining ≥10 Letters: Treatment Difference at Weeks 40-4895% CI: [-2, 12.7]
Comparison: Gaining ≥5 Letters: Treatment Difference at Weeks 40-4895% CI: [-6.6, 8.9]
Comparison: Gaining ≥0 Letters: Treatment Difference at Weeks 40-4895% CI: [-7.9, 5.4]
Secondary
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112
Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 112. Treatment interval at a given visit is defined as the treatment interval decision followed at that visit. Treatment interval at Week 112 is calculated using data recorded at Week 108. The 95% confidence interval (CI) is a rounding of 95.03% CI.
Time frame: Weeks 108 and 112
Population: The analysis included all participants randomized to the faricimab arm who completed their Week 112 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112 | Once Every 8 Weeks | 25.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112 | Once Every 12 Weeks | 15.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112 | Once Every 16 Weeks | 59.0 Percentage of participants |
Secondary
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48
Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 48. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.
Time frame: Week 48
Population: The analysis included all participants randomized to the faricimab arm who completed their Week 48 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48 | Once Every 8 Weeks | 20.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48 | Once Every 12 Weeks | 34.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48 | Once Every 16 Weeks | 45.7 Percentage of participants |
Secondary
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60
Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 60. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.
Time frame: Week 60
Population: The analysis included all participants randomized to the faricimab arm who completed their Week 60 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60 | Once Every 8 Weeks | 20.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60 | Once Every 12 Weeks | 33.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60 | Once Every 16 Weeks | 46.4 Percentage of participants |
Secondary
Percentage of Participants Who Tested 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: Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112
Population: The immunogenicity-analysis population includes all participants randomized to the faricimab arm with at least one determinant ADA assessment. Only those with at least one post-baseline ADA assessment were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Total Treatment-Emergent ADA-Positive | 11.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study | Treatment-Induced ADA-Positive | 11.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants Who Tested 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 Absence of Intraretinal Cysts in the Study Eye Over Time
Time frame: Up to 112 weeks
Population: The percentage of participants with absence of intraretinal cysts over time was planned but it was not evaluated (i.e., 0 participants analyzed) because the absence of intraretinal fluid and the absence of intraretinal cysts are described by the same variable during reading center grading.
Secondary
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre \[mm\]). The weighted estimates of the percentage of participants with absence of intraretinal and subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 28 | 54.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 4 | 60.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 32 | 71.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 48 | 63.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 36 | 59.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 8 | 74.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 40 | 64.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 56 | 67.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 44 | 51.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 12 | 77.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 52 | 68.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 16 | 78.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 60 | 48.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 104 | 63.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 20 | 64.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 108 | 60.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 112 | 65.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 24 | 57.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 112 | 54.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 24 | 48.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 48 | 47.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 52 | 68.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 108 | 63.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 4 | 49.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 8 | 63.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 16 | 44.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 20 | 62.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 28 | 66.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 32 | 51.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 36 | 66.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 40 | 52.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 44 | 65.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 56 | 55.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 60 | 62.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 104 | 59.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time | Week 12 | 66.3 Percentage of participants |
Secondary
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre \[mm\]). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 4 | 89.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 8 | 87.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 12 | 89.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 16 | 89.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 20 | 82.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 24 | 80.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 28 | 76.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 32 | 86.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 36 | 79.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 40 | 82.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 44 | 75.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 48 | 82.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 52 | 83.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 56 | 84.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 60 | 72.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 104 | 80.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 108 | 77.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 112 | 82.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 56 | 80.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 4 | 85.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 40 | 77.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 8 | 84.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 112 | 76.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 12 | 85.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 44 | 84.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 16 | 76.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 60 | 82.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 20 | 83.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 48 | 74.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 24 | 77.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 108 | 84.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 28 | 85.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 52 | 85.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 32 | 79.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 104 | 80.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time | Week 36 | 83.5 Percentage of participants |
Secondary
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Pigment epithelial detachment was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of pigment epithelial detachment were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 36 | 4.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 40 | 7.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 44 | 3.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 4 | 5.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 48 | 3.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 8 | 3.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 52 | 2.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 20 | 2.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 56 | 2.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 24 | 3.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 60 | 4.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 28 | 2.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 104 | 3.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 16 | 1.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 108 | 3.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 32 | 3.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 112 | 4.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 12 | 2.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 112 | 8.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 12 | 2.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 16 | 4.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 20 | 3.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 24 | 4.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 36 | 6.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 8 | 4.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 28 | 5.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 32 | 3.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 40 | 9.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 44 | 8.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 48 | 7.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 52 | 3.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 56 | 5.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 60 | 6.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 104 | 4.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 108 | 7.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time | Week 4 | 4.9 Percentage of participants |
Secondary
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), 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 95.03% CI.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 4 | 67.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 8 | 84.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 12 | 87.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 16 | 89.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 20 | 75.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 24 | 70.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 28 | 71.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 32 | 82.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 36 | 74.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 40 | 78.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 44 | 69.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 48 | 75.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 52 | 80.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 56 | 79.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 60 | 67.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 104 | 79.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 108 | 79.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 112 | 80.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 56 | 70.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 4 | 58.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 40 | 67.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 8 | 76.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 112 | 73.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 12 | 78.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 44 | 78.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 16 | 59.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 60 | 77.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 20 | 76.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 48 | 65.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 24 | 63.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 108 | 77.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 28 | 78.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 52 | 79.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 32 | 65.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 104 | 74.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time | Week 36 | 79.9 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. Multiple occurrences of the same AE in one individual are counted only once. 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 (IOI).
Time frame: From first dose of study drug through end of study (up to 112 weeks)
Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With at Least One Adverse Event | Adverse Event (AE) | 88.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Adverse Event | Serious AE (SAE) | 24.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Adverse Event | AE Leading to Withdrawal from Study Treatment | 3.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Adverse Event | AE of Special Interest (AESI) | 4.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Adverse Event | AE of Special Interest (AESI) | 6.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Adverse Event | Adverse Event (AE) | 89.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Adverse Event | AE Leading to Withdrawal from Study Treatment | 2.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Adverse Event | Serious AE (SAE) | 27.7 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. Multiple occurrences of the same AE in one individual are counted only once. 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. 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 112 weeks)
Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With at Least One Non-Ocular Adverse Event | Adverse Event (AE) | 75.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Non-Ocular Adverse Event | Serious AE (SAE) | 19.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE Leading to Withdrawal from Study Treatment | 1.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE of Special Interest (AESI) | 0.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE of Special Interest (AESI) | 0.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Non-Ocular Adverse Event | Adverse Event (AE) | 72.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Non-Ocular Adverse Event | AE Leading to Withdrawal from Study Treatment | 2.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Non-Ocular Adverse Event | Serious AE (SAE) | 22.6 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. Multiple occurrences of the same AE in one individual are counted only once. 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 (IOI).
Time frame: From first dose of study drug through end of study (up to 112 weeks)
Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Adverse Event (AE) | 55.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Serious AE (SAE) | 4.2 Percentage of participants |
| Arm A: Faricimab | 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 | 1.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related AE | 4.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related SAE | 1.2 Percentage of participants |
| Arm A: Faricimab | 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) | 3.6 Percentage of participants |
| Arm A: Faricimab | 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 | 2.7 Percentage of participants |
| Arm A: Faricimab | 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 | 0.3 Percentage of participants |
| Arm A: Faricimab | 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 | 0.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AE | 39.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: SAE | 1.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI | 1.2 Percentage of participants |
| Arm A: Faricimab | 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 | 0.9 Percentage of participants |
| Arm A: Faricimab | 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 | 0.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: SAE | 3.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Adverse Event (AE) | 56.5 Percentage of participants |
| Arm B: Aflibercept | 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 | 0.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Serious AE (SAE) | 3.9 Percentage of participants |
| Arm B: Aflibercept | 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 | 2.1 Percentage of participants |
| Arm B: Aflibercept | 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 | 0.6 Percentage of participants |
| Arm B: Aflibercept | 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 | 0.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Study Eye: Treatment-related AE | 2.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AESI | 3.0 Percentage of participants |
| Arm B: Aflibercept | 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 |
| Arm B: Aflibercept | Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye | Fellow Eye: AE | 44.3 Percentage of participants |
| Arm B: Aflibercept | 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) | 3.9 Percentage of participants |
| Arm B: Aflibercept | 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 | 0.9 Percentage of participants |
| Arm B: Aflibercept | 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 | 3.0 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 40, 44, and 48
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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI.
Time frame: Baseline, average of Weeks 40, 44, and 48
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | 6.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | 6.9 Percentage of participants |
Comparison: Treatment Difference in CMH Weighted Percentages at Weeks 40-4895% CI: [-4.2, 3.3]
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 60 | 6.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 32 | 6.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 64 | 7.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 12 | 4.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 68 | 7.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 36 | 6.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 72 | 8.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 16 | 5.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 76 | 7.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 40 | 7.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 80 | 8.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 4 | 5.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 84 | 7.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 44 | 7.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 88 | 9.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 20 | 5.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 92 | 9.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 48 | 7.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 96 | 8.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 24 | 4.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 100 | 8.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 52 | 8.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 104 | 9.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 8 | 5.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 108 | 7.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 56 | 6.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 112 | 8.2 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 28 | 5.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 112 | 11.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 4 | 5.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 8 | 5.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 16 | 6.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 20 | 6.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 24 | 5.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 28 | 5.2 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 32 | 6.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 36 | 6.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 40 | 8.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 44 | 6.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 48 | 7.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 52 | 9.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 56 | 7.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 60 | 8.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 64 | 9.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 68 | 9.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 72 | 10.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 76 | 10.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 80 | 10.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 84 | 11.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 88 | 11.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 92 | 12.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 96 | 11.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 100 | 11.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 104 | 11.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 108 | 10.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time | Week 12 | 5.6 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 40, 44, and 48
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 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 letters vs. ≥69 letters), baseline LLD (≥33 letters and \<33 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 95.03% CI.
Time frame: Baseline, average of Weeks 40, 44, and 48
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | 56.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48 | 57.0 Percentage of participants |
Comparison: Treatment Difference in CMH Weighted Percentages at Weeks 40-4895% CI: [-7.7, 6.6]
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and \<33 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 95.03% 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, 100, 104, 108, and 112
Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 60 | 57.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 20 | 59.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 64 | 62.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 36 | 59.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 68 | 61.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 8 | 54.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 72 | 59.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 40 | 57.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 76 | 58.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 24 | 59.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 80 | 56.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 44 | 59.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 84 | 57.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 16 | 60.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 88 | 59.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 48 | 58.9 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 92 | 58.6 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 28 | 57.5 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 96 | 59.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 52 | 61.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 100 | 58.1 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 12 | 58.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 104 | 59.8 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 56 | 59.0 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 108 | 56.4 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 32 | 57.7 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 112 | 56.3 Percentage of participants |
| Arm A: Faricimab | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 4 | 52.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 112 | 54.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 4 | 50.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 8 | 50.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 12 | 53.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 16 | 53.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 20 | 54.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 24 | 54.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 28 | 59.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 32 | 58.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 36 | 59.6 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 40 | 58.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 44 | 59.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 48 | 58.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 52 | 57.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 56 | 55.9 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 60 | 56.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 64 | 57.7 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 68 | 59.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 72 | 57.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 76 | 55.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 80 | 55.5 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 84 | 58.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 88 | 54.1 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 92 | 57.8 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 96 | 58.3 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 100 | 57.4 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 104 | 58.0 Percentage of participants |
| Arm B: Aflibercept | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time | Week 108 | 56.4 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 at Baseline, Weeks 4, 16, 20, 48, 76, and 112
Population: This analysis only includes Arm A participants who received treatment with faricimab in the pharmacokinetic-evaluable population, which includes safety-evaluable participants 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 |
|---|---|---|---|---|
| Arm A: Faricimab | Plasma Concentration of Faricimab Over Time | Baseline | 0.0000 micrograms per millilitre (μg/mL) | Standard Deviation 0.0005 |
| Arm A: Faricimab | Plasma Concentration of Faricimab Over Time | Week 4 | 0.0288 micrograms per millilitre (μg/mL) | Standard Deviation 0.0194 |
| Arm A: Faricimab | Plasma Concentration of Faricimab Over Time | Week 16 | 0.0337 micrograms per millilitre (μg/mL) | Standard Deviation 0.0266 |
| Arm A: Faricimab | Plasma Concentration of Faricimab Over Time | Week 20 | 0.0044 micrograms per millilitre (μg/mL) | Standard Deviation 0.0062 |
| Arm A: Faricimab | Plasma Concentration of Faricimab Over Time | Week 48 | 0.0139 micrograms per millilitre (μg/mL) | Standard Deviation 0.0175 |
| Arm A: Faricimab | Plasma Concentration of Faricimab Over Time | Week 76 | 0.0057 micrograms per millilitre (μg/mL) | Standard Deviation 0.0109 |
| Arm A: Faricimab | Plasma Concentration of Faricimab Over Time | Week 112 | 0.0099 micrograms per millilitre (μg/mL) | Standard Deviation 0.014 |