Age-Related Macular Degeneration
Conditions
Keywords
neovascular age-related macular degeneration, nAMD, intravitreal injection, IVT, anti-VEGF, brolucizumab, aflibercept, EYLEA, double-masked, MERLIN, BEOVU
Brief summary
This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.
Detailed description
This was a Phase III, multi-center, randomized, double-masked, parallel group study with 2 masked arms in which participants were randomized 2:1 to receive brolucizumab or aflibercept. All participants had study visits every 4 weeks through week 104. The study consisted of three study periods: Screening Period: The screening period lasted up to 2 weeks prior to administration of the first dose of study treatment, dependent upon confirmation of the patient meeting eligibility criteria. Double-Masked Treatment Period: Participants meeting eligibility criteria entered the treatment period and were randomized in a 2:1 ratio into one of the following 2 masked treatment arms at the Baseline visit: Brolucizumab 6 mg injected every 4 weeks or Aflibercept 2 mg injected every 4 weeks. Treatment period lasted up to week 100. Safety Follow up Period: Participants were followed up for safety during 4 weeks after the last dose of study treatment. Including the Screening Period, the total study duration for a participant was up to 106 weeks. Some participants were eligible to continue into an extension study in order to receive treatment with brolucizumab (a) after completing the 104 -week double-masked treatment period, (b) upon meeting all inclusion/exclusion criteria for the extension study, and (c) based on Investigator's judgment that the participant was expected to benefit from treatment with brolucizumab.
Interventions
BIOLOGICALBrolucizumab
6 mg/0.05mL solution for intravitreal injection
BIOLOGICALAflibercept
2 mg/0.05mL solution for intravitreal injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
multicenter, randomized, double-masked
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Diagnosis of wet age-related macular degeneration (AMD) * Currently receiving anti-VEGF injections
Exclusion criteria
* Active infection or inflammation in either eye * Significant fibrosis in the study eye * Recent ocular surgery * Uncontrolled glaucoma * Use of medications as specified in the protocol * Pregnant, nursing * Of child-bearing potential unless using highly effective method of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 | Baseline, week 52 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. A positive change from baseline represents better functioning. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. Last observation carried forward (LOCF) was used for the imputation of missing values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | 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 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | 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 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | 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 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | 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 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | 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 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | 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 and 104 | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Change in Central Subfield Thickness (CST) From Baseline | 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 and 104 | CST was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A negative change from baseline is a favorable outcome. CST assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. |
| Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Baseline, weeks 52 and 104 | Visual Acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. VA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of participants with no change or gain in VA compared to baseline was reported. VA stabilization or improvement is defined as a change from baseline no worse than 5 letters loss in VA compared to Baseline. Baseline VA was defined as the last measurement on or prior to the baseline visit. VA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
| Number of Participants With Subretinal Fluid (SRF) | 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 and 104 | SRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of SRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. |
| Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | 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 and 104 | Sub-RPE fluid was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of sub-RPE fluid in participants with sub-RPE fluid at baseline was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. |
| Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | 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 and 104 | Intraretinal fluid (IRF), Subretinal fluid (SRF) and Sub-Retinal Pigment Epithelium fluid (sub-RPE) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with fluid-free status (simultaneous absence of IRF, SRF, and sub-RPE) was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. |
| Time to First Dry Retina (no IRF or SRF) | Baseline, Up to Week 104 (assessments every 4 weeks) | Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A dry retina is defined as no IRF or SRF at the respective visit. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered. |
| Time to Sustained Dry Retina (no IRF or SRF at ≥ 2 Consecutive Visits) | Baseline, Up to Week 104 (assessments every 4 weeks) | Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A sustained dry retina is defined as no IRF or SRF at 2 or more consecutive visits. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered. |
| Number of Participants With Anti-drug Antibody (ADA) Negative Status | Baseline, weeks 4, 12, 24, 36, 52, 76 and 104 | A blood sample was collected for anti-drug antibody assessment. ADA negative status = ADA negative result at the corresponding study visit. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments were taken at the scheduled timepoints. A negative Titer was used to assess the ADA status for the brolucizumab arm. |
| Free Brolucizumab Serum Concentration | pre-dose a baseline, weeks 4, 12, 24, 36, 52, 76 and 104 | A blood sample was collected for Free Brolucizumab serum concentration assessment. This outcome measure was pre-specified for the brolucizumab arm only. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments. Values below the limit of quantification (BLQ) (\<0.5 ng/mL) were replaced by one half of the LLOQ (0.25 ng/mL) in the calculation of the summary statistics. For the Mean score at each visit, if the calculated value was less than 0.5, then NA was displayed instead; meaning that the score is below the limit of quantitation (\<0.5 ng/mL). |
| Number of Participants With Intraretinal Fluid (IRF) | 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 and 104 | IRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of IRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. | 356 |
| Aflibercept Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. | 179 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 10 | 4 |
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Physician Decision | 2 | 3 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Study Terminated by Sponsor | 104 | 55 |
| Overall Study | Withdrawal by Subject | 57 | 25 |
Baseline characteristics
| Characteristic | Aflibercept | Total | Brolucizumab |
|---|---|---|---|
| Age, Continuous | 76.1 Years STANDARD_DEVIATION 7.8 | 76.3 Years STANDARD_DEVIATION 7.58 | 76.4 Years STANDARD_DEVIATION 7.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 176 Participants | 523 Participants | 347 Participants |
| Sex: Female, Male Female | 107 Participants | 302 Participants | 195 Participants |
| Sex: Female, Male Male | 72 Participants | 233 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 10 / 356 | 4 / 179 | 14 / 535 |
| other Total, other adverse events | 287 / 356 | 149 / 179 | 436 / 535 |
| serious Total, serious adverse events | 75 / 356 | 45 / 179 | 120 / 535 |
Outcome results
Primary
Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. A positive change from baseline represents better functioning. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, week 52
Population: All randomized participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab | Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 | 0.3 Score on a scale | Standard Deviation 9.02 |
| Aflibercept | Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 | 0.9 Score on a scale | Standard Deviation 6.51 |
p-value: 0.453795% CI: [-2.1, 0.9]Pairwise ANOVA
Secondary
Change in Central Subfield Thickness (CST) From Baseline
CST was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A negative change from baseline is a favorable outcome. CST assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
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 and 104
Population: All randomized participants
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 28 | -64.3 µm | Standard Error 3.57 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 8 | -59.7 µm | Standard Error 3.16 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 12 | -62.3 µm | Standard Error 3.24 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 16 | -61.7 µm | Standard Error 3.36 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 20 | -64.6 µm | Standard Error 3.46 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 24 | -63.8 µm | Standard Error 3.61 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 4 | -55.1 µm | Standard Error 2.93 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 32 | -65.2 µm | Standard Error 3.7 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 36 | -64.0 µm | Standard Error 3.81 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 40 | -64.9 µm | Standard Error 3.76 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 44 | -66.7 µm | Standard Error 3.71 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 48 | -68.9 µm | Standard Error 3.76 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 52 | -69.0 µm | Standard Error 3.88 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 56 | -70.5 µm | Standard Error 3.85 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 60 | -70.0 µm | Standard Error 4 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 64 | -71.2 µm | Standard Error 3.99 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 68 | -71.3 µm | Standard Error 4.07 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 72 | -71.2 µm | Standard Error 4.08 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 76 | -71.4 µm | Standard Error 4.06 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 80 | -72.0 µm | Standard Error 4.13 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 84 | -71.3 µm | Standard Error 4.15 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 88 | -70.9 µm | Standard Error 4.14 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 92 | -69.1 µm | Standard Error 4.21 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 96 | -70.5 µm | Standard Error 4.13 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 100 | -69.8 µm | Standard Error 4.14 |
| Brolucizumab | Change in Central Subfield Thickness (CST) From Baseline | Week 104 | -71.3 µm | Standard Error 4.16 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 80 | -45.3 µm | Standard Error 5.85 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 4 | -29.8 µm | Standard Error 4.15 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 56 | -43.9 µm | Standard Error 5.45 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 8 | -35.4 µm | Standard Error 4.48 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 100 | -47.0 µm | Standard Error 5.87 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 12 | -37.3 µm | Standard Error 4.59 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 60 | -43.6 µm | Standard Error 5.66 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 16 | -39.2 µm | Standard Error 4.75 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 84 | -48.4 µm | Standard Error 5.88 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 20 | -41.4 µm | Standard Error 4.9 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 64 | -41.5 µm | Standard Error 5.65 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 24 | -40.8 µm | Standard Error 5.11 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 96 | -43.5 µm | Standard Error 5.85 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 28 | -35.5 µm | Standard Error 5.05 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 68 | -40.8 µm | Standard Error 5.77 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 32 | -40.4 µm | Standard Error 5.23 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 88 | -44.6 µm | Standard Error 5.87 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 36 | -42.3 µm | Standard Error 5.39 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 72 | -42.6 µm | Standard Error 5.78 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 40 | -38.2 µm | Standard Error 5.32 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 104 | -48.3 µm | Standard Error 5.9 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 44 | -40.2 µm | Standard Error 5.24 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 76 | -46.2 µm | Standard Error 5.76 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 48 | -40.7 µm | Standard Error 5.32 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 92 | -46.4 µm | Standard Error 5.97 |
| Aflibercept | Change in Central Subfield Thickness (CST) From Baseline | Week 52 | -37.0 µm | Standard Error 5.5 |
Secondary
Free Brolucizumab Serum Concentration
A blood sample was collected for Free Brolucizumab serum concentration assessment. This outcome measure was pre-specified for the brolucizumab arm only. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments. Values below the limit of quantification (BLQ) (\<0.5 ng/mL) were replaced by one half of the LLOQ (0.25 ng/mL) in the calculation of the summary statistics. For the Mean score at each visit, if the calculated value was less than 0.5, then NA was displayed instead; meaning that the score is below the limit of quantitation (\<0.5 ng/mL).
Time frame: pre-dose a baseline, weeks 4, 12, 24, 36, 52, 76 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. This outcome measure was pre-specified for the brolucizumab arm only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab | Free Brolucizumab Serum Concentration | Baseline | NA ng / mL | — |
| Brolucizumab | Free Brolucizumab Serum Concentration | Week 4 | 0.69 ng / mL | Standard Deviation 2.47 |
| Brolucizumab | Free Brolucizumab Serum Concentration | Week 12 | 0.81 ng / mL | Standard Deviation 2.33 |
| Brolucizumab | Free Brolucizumab Serum Concentration | Week 24 | 0.69 ng / mL | Standard Deviation 2.1 |
| Brolucizumab | Free Brolucizumab Serum Concentration | Week 36 | 0.54 ng / mL | Standard Deviation 1.32 |
| Brolucizumab | Free Brolucizumab Serum Concentration | Week 52 | NA ng / mL | — |
| Brolucizumab | Free Brolucizumab Serum Concentration | Week 76 | NA ng / mL | — |
| Brolucizumab | Free Brolucizumab Serum Concentration | Week 104 | NA ng / mL | — |
Secondary
Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.
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 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 28 | 78 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 8 | 49 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 12 | 62 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 16 | 64 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 20 | 67 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 24 | 77 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 4 | 48 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 32 | 75 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 36 | 69 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 40 | 65 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 44 | 60 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 48 | 66 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 52 | 67 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 56 | 71 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 60 | 67 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 64 | 72 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 68 | 61 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 72 | 62 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 76 | 62 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 80 | 66 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 84 | 59 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 88 | 53 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 92 | 46 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 96 | 50 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 100 | 39 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 104 | 42 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 80 | 29 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 4 | 18 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 56 | 31 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 8 | 20 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 100 | 15 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 12 | 20 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 60 | 26 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 16 | 28 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 84 | 29 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 20 | 26 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 64 | 28 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 24 | 34 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 96 | 18 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 28 | 36 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 68 | 31 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 32 | 38 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 88 | 24 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 36 | 38 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 72 | 29 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 40 | 37 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 104 | 19 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 44 | 31 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 76 | 24 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 48 | 34 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 92 | 21 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 52 | 32 Participants |
Secondary
Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.
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 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 28 | 63 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 8 | 37 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 12 | 51 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 16 | 56 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 20 | 51 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 24 | 64 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 4 | 43 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 32 | 57 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 36 | 50 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 40 | 54 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 44 | 47 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 48 | 50 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 52 | 50 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 56 | 56 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 60 | 56 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 64 | 58 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 68 | 50 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 72 | 49 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 76 | 54 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 80 | 53 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 84 | 44 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 88 | 46 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 92 | 42 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 96 | 39 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 100 | 30 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 104 | 30 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 80 | 20 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 4 | 14 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 56 | 22 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 8 | 16 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 100 | 11 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 12 | 16 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 60 | 21 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 16 | 23 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 84 | 18 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 20 | 15 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 64 | 22 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 24 | 25 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 96 | 11 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 28 | 28 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 68 | 23 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 32 | 25 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 88 | 18 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 36 | 26 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 72 | 19 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 40 | 26 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 104 | 14 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 44 | 27 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 76 | 14 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 48 | 22 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 92 | 14 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 52 | 27 Participants |
Secondary
Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.
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 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 28 | 129 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 8 | 98 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 12 | 113 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 16 | 119 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 20 | 123 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 24 | 125 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 4 | 94 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 32 | 122 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 36 | 108 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 40 | 111 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 44 | 103 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 48 | 117 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 52 | 108 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 56 | 103 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 60 | 108 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 64 | 106 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 68 | 96 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 72 | 108 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 76 | 107 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 80 | 106 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 84 | 102 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 88 | 93 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 92 | 79 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 96 | 76 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 100 | 70 Participants |
| Brolucizumab | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 104 | 65 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 80 | 50 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 4 | 35 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 56 | 48 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 8 | 43 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 100 | 24 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 12 | 48 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 60 | 46 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 16 | 53 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 84 | 43 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 20 | 47 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 64 | 51 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 24 | 57 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 96 | 31 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 28 | 61 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 68 | 46 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 32 | 57 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 88 | 42 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 36 | 58 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 72 | 46 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 40 | 62 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 104 | 28 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 44 | 50 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 76 | 48 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 48 | 54 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 92 | 36 Participants |
| Aflibercept | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 52 | 52 Participants |
Secondary
Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.
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 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 28 | 14 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 8 | 5 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 12 | 9 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 16 | 13 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 20 | 14 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 24 | 8 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 4 | 4 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 32 | 10 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 36 | 9 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 40 | 13 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 44 | 17 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 48 | 20 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 52 | 24 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 56 | 20 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 60 | 21 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 64 | 24 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 68 | 20 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 72 | 21 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 76 | 24 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 80 | 26 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 84 | 20 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 88 | 21 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 92 | 20 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 96 | 18 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 100 | 15 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 104 | 17 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 80 | 13 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 4 | 6 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 56 | 5 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 8 | 5 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 100 | 7 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 12 | 5 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 60 | 8 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 16 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 84 | 10 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 20 | 5 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 64 | 10 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 24 | 6 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 96 | 8 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 28 | 9 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 68 | 10 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 32 | 8 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 88 | 14 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 36 | 10 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 72 | 11 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 40 | 5 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 104 | 7 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 44 | 6 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 76 | 13 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 48 | 9 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 92 | 9 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | Week 52 | 7 Participants |
Secondary
Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.
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 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 28 | 4 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 8 | 2 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 12 | 3 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 16 | 4 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 20 | 5 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 24 | 3 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 4 | 2 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 32 | 6 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 36 | 3 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 40 | 5 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 44 | 6 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 48 | 10 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 52 | 14 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 56 | 13 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 60 | 13 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 64 | 10 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 68 | 10 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 72 | 10 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 76 | 13 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 80 | 12 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 84 | 7 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 88 | 10 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 92 | 11 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 96 | 9 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 100 | 7 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 104 | 10 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 80 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 4 | 1 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 56 | 2 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 8 | 1 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 100 | 5 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 12 | 2 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 60 | 3 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 16 | 1 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 84 | 6 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 20 | 1 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 64 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 24 | 1 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 96 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 28 | 3 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 68 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 32 | 3 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 88 | 5 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 36 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 72 | 3 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 40 | 3 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 104 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 44 | 3 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 76 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 48 | 3 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 92 | 4 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | Week 52 | 2 Participants |
Secondary
Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.
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 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 28 | 46 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 8 | 38 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 12 | 33 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 16 | 34 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 20 | 47 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 24 | 40 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 4 | 31 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 32 | 45 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 36 | 44 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 40 | 46 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 44 | 45 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 48 | 46 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 52 | 50 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 56 | 46 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 60 | 51 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 64 | 47 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 68 | 50 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 72 | 59 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 76 | 48 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 80 | 49 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 84 | 51 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 88 | 37 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 92 | 43 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 96 | 42 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 100 | 40 Participants |
| Brolucizumab | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 104 | 40 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 80 | 27 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 4 | 16 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 56 | 17 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 8 | 17 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 100 | 19 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 12 | 22 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 60 | 23 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 16 | 19 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 84 | 27 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 20 | 15 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 64 | 26 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 24 | 20 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 96 | 19 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 28 | 24 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 68 | 28 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 32 | 24 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 88 | 24 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 36 | 24 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 72 | 25 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 40 | 17 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 104 | 23 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 44 | 17 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 76 | 31 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 48 | 23 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 92 | 24 Participants |
| Aflibercept | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | Week 52 | 24 Participants |
Secondary
Number of Participants With Anti-drug Antibody (ADA) Negative Status
A blood sample was collected for anti-drug antibody assessment. ADA negative status = ADA negative result at the corresponding study visit. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments were taken at the scheduled timepoints. A negative Titer was used to assess the ADA status for the brolucizumab arm.
Time frame: Baseline, weeks 4, 12, 24, 36, 52, 76 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. This outcome measure was pre-specified for the brolucizumab arm only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Week 52 | 106 Participants |
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Baseline | 77 Participants |
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Week 4 | 121 Participants |
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Week 12 | 122 Participants |
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Week 24 | 118 Participants |
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Week 36 | 117 Participants |
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Week 76 | 100 Participants |
| Brolucizumab | Number of Participants With Anti-drug Antibody (ADA) Negative Status | Week 104 | 101 Participants |
Secondary
Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid)
Intraretinal fluid (IRF), Subretinal fluid (SRF) and Sub-Retinal Pigment Epithelium fluid (sub-RPE) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with fluid-free status (simultaneous absence of IRF, SRF, and sub-RPE) was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 28 | 124 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 8 | 110 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 12 | 120 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 16 | 126 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 20 | 114 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 24 | 122 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 4 | 82 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 32 | 123 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 36 | 111 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 40 | 117 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 44 | 122 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 48 | 116 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 52 | 107 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 56 | 127 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 60 | 125 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 64 | 129 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 68 | 124 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 72 | 133 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 76 | 133 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 80 | 136 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 84 | 135 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 88 | 130 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 92 | 128 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 96 | 127 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 100 | 130 Participants |
| Brolucizumab | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 104 | 134 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 80 | 26 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 4 | 16 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 56 | 28 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 8 | 24 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 100 | 34 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 12 | 22 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 60 | 30 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 16 | 23 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 84 | 27 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 20 | 20 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 64 | 28 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 24 | 28 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 96 | 32 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 28 | 23 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 68 | 28 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 32 | 24 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 88 | 32 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 36 | 32 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 72 | 31 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 40 | 23 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 104 | 38 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 44 | 25 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 76 | 25 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 48 | 27 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 92 | 31 Participants |
| Aflibercept | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Week 52 | 25 Participants |
Secondary
Number of Participants With Intraretinal Fluid (IRF)
IRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of IRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 28 | 266 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 8 | 276 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 12 | 279 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 16 | 274 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 20 | 266 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 24 | 266 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 4 | 272 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 32 | 262 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 36 | 255 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 40 | 255 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 44 | 263 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 48 | 265 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 52 | 265 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 56 | 268 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 60 | 278 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 64 | 276 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 68 | 269 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 72 | 271 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 76 | 279 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 80 | 280 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 84 | 274 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 88 | 270 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 92 | 273 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 96 | 270 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 100 | 275 Participants |
| Brolucizumab | Number of Participants With Intraretinal Fluid (IRF) | Week 104 | 273 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 80 | 122 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 4 | 132 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 56 | 125 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 8 | 131 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 100 | 126 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 12 | 125 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 60 | 125 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 16 | 126 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 84 | 124 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 20 | 124 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 64 | 126 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 24 | 126 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 96 | 123 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 28 | 128 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 68 | 127 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 32 | 124 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 88 | 122 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 36 | 124 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 72 | 123 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 40 | 121 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 104 | 124 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 44 | 122 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 76 | 122 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 48 | 117 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 92 | 123 Participants |
| Aflibercept | Number of Participants With Intraretinal Fluid (IRF) | Week 52 | 120 Participants |
Secondary
Number of Participants With Subretinal Fluid (SRF)
SRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of SRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 28 | 207 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 4 | 161 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 8 | 193 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 12 | 205 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 16 | 209 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 20 | 200 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 24 | 211 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 32 | 211 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 36 | 200 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 40 | 211 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 44 | 211 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 48 | 205 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 52 | 203 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 56 | 211 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 60 | 207 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 64 | 213 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 68 | 212 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 72 | 216 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 76 | 220 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 80 | 220 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 84 | 228 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 88 | 225 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 92 | 222 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 96 | 224 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 100 | 223 Participants |
| Brolucizumab | Number of Participants With Subretinal Fluid (SRF) | Week 104 | 227 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 80 | 66 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 56 | 65 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 4 | 41 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 100 | 74 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 60 | 64 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 12 | 46 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 84 | 67 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 16 | 60 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 64 | 63 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 20 | 53 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 96 | 73 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 24 | 59 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 8 | 47 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 28 | 54 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 68 | 64 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 32 | 55 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 88 | 73 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 36 | 69 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 72 | 72 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 40 | 59 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 104 | 79 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 44 | 58 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 76 | 67 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 48 | 62 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 92 | 75 Participants |
| Aflibercept | Number of Participants With Subretinal Fluid (SRF) | Week 52 | 65 Participants |
Secondary
Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid
Sub-RPE fluid was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of sub-RPE fluid in participants with sub-RPE fluid at baseline was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 56 | 240 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 16 | 235 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 60 | 238 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 32 | 237 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 64 | 235 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 4 | 191 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 68 | 231 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 36 | 227 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 72 | 236 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 20 | 232 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 76 | 233 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 40 | 238 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 80 | 234 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 12 | 223 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 84 | 233 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 44 | 235 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 88 | 234 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 24 | 231 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 92 | 236 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 8 | 213 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 96 | 237 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 52 | 228 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 100 | 242 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 28 | 229 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 104 | 237 Participants |
| Brolucizumab | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 48 | 228 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 104 | 100 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 4 | 89 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 8 | 98 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 12 | 98 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 16 | 105 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 20 | 99 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 24 | 101 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 28 | 95 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 32 | 101 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 36 | 101 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 40 | 101 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 44 | 103 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 48 | 105 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 52 | 113 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 56 | 102 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 60 | 107 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 64 | 99 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 68 | 98 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 72 | 96 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 76 | 96 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 80 | 96 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 84 | 100 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 88 | 97 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 92 | 94 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 96 | 101 Participants |
| Aflibercept | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Week 100 | 104 Participants |
Secondary
Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104
Visual Acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. VA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of participants with no change or gain in VA compared to baseline was reported. VA stabilization or improvement is defined as a change from baseline no worse than 5 letters loss in VA compared to Baseline. Baseline VA was defined as the last measurement on or prior to the baseline visit. VA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.
Time frame: Baseline, weeks 52 and 104
Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab | Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Week 52 | 232 Participants |
| Brolucizumab | Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Week 104 | 122 Participants |
| Aflibercept | Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Week 52 | 132 Participants |
| Aflibercept | Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Week 104 | 63 Participants |
Secondary
Time to First Dry Retina (no IRF or SRF)
Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A dry retina is defined as no IRF or SRF at the respective visit. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered.
Time frame: Baseline, Up to Week 104 (assessments every 4 weeks)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brolucizumab | Time to First Dry Retina (no IRF or SRF) | 87.0 Days |
| Aflibercept | Time to First Dry Retina (no IRF or SRF) | 646.0 Days |
Secondary
Time to Sustained Dry Retina (no IRF or SRF at ≥ 2 Consecutive Visits)
Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A sustained dry retina is defined as no IRF or SRF at 2 or more consecutive visits. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered.
Time frame: Baseline, Up to Week 104 (assessments every 4 weeks)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brolucizumab | Time to Sustained Dry Retina (no IRF or SRF at ≥ 2 Consecutive Visits) | 148.0 Days |
| Aflibercept | Time to Sustained Dry Retina (no IRF or SRF at ≥ 2 Consecutive Visits) | NA Days |