| Primary | Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye. | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00010.6± 0.85
- OG00111.9± 0.85
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | | 0.013 | | LS mean difference | -1.3 | Standard Error of the Mean | 1.20 | 2-Sided | 95 | -3.7 | 1.1 | | | | | Superiority | | |
|
| Primary | Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 40 Through Week 52 for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Week 40 to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Change From Baseline by Visit up to Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- observed. All randomized subjects who received at least one intravitreal treatment (IVT) injection of the study treatment and had a valid value of the outcome measure at each timepoint. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 4 Through Week 52 for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Week 4 to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 20 Through Week 52 for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Week 20 to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 28 Through Week 52 for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Week 28 to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit | The estimate for the proportion of subjects with a positive q12w treatment status was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need', applying a 'q8w-need' allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety. As a result, the probability that subjects in brolucizumab arm do not need a q8w treatment (and therefore are maintained on a q12w treatment) up to the visit is reported in the table. | FAS - Efficacy/Safety approach | Posted | | Number | 95% Confidence Interval | Probability | | Baseline (Week 0), Week 32, Week 36 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit, Within Those Subjects With no q8w-need During the Initial q12w Cycle | The estimate for the proportion of subjects with a positive q12w treatment status was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need', applying a 'q8w-need' allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety. As a result, the probability that subjects in brolucizumab arm do not need a q8w treatment (and therefore are maintained on a q12w treatment) up to the visit is reported in the table. | FAS - Efficacy/Safety approach. Participants in the Full Analysis Set with no identified q8w-need at Week 32 and Week 36. | Posted | | Number | 95% Confidence Interval | Probability | | Week 36 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number and Percentage of Patients Who Gained in ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Count of Participants | | Participants | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Time to Achieve Gain of >= 5 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | | Posted | | Number | 95% Confidence Interval | Probability of BCVA gain | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Time to Achieve Gain of >= 10 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | | Posted | | Number | 95% Confidence Interval | Probability of BCVA gain | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Time to Achieve Gain of >= 15 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | | Posted | | Number | 95% Confidence Interval | Probability of BCVA gain | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number and Percentage of Patients Who Lost ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Count of Participants | | Participants | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Proportion of Patients Who Have Absolute BCVA ≥73 ETDRS Letters at Each Post-baseline Visit for the Study Eye | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | | Posted | | Count of Participants | | Participants | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit - Week 32 | To evaluate the efficacy related to dosing regimen of brolucizumab | Full Analysis Set - Observed (Patients with a valid observed value for the outcome measure.) | Posted | | Count of Participants | | Participants | | Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at Week 36, and Week 48 | To evaluate the efficacy related to dosing regimen of brolucizumab | Full Analysis Set - Observed | Posted | | Count of Participants | | Participants | | Week 36, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Change From Baseline at Week 52 in Central Subfield Thickness (CSFT) for the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | micrometer | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Average Change From Baseline Over the Period Week 40 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | micrometer | | Baseline, over the period of Week 40 to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Average Change From Baseline Over the Period Week 4 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Least Squares Mean | Standard Error | micrometer | | Baseline, over the period of Week 4 to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number and Percentage of Patients Who Have CSFT (<280 Microns) at Each Assessment Visit for the Study Eye | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. | | Posted | | Count of Participants | | Participants | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number (%) of Patients With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS DRSS of at Least 61 by Week 52 for the Study Eye Among the Subset of Non-PDR Subjects at Screening | As evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were converted and categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | Full Analysis Set - LOCF. Subset of non-Proliferative diabetic retinopathy (PDR) subjects at screening | Posted | | Count of Participants | | Participants | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number (%) of Patients With Presence of Leakage in the Study Eye on Fluorescein Angiography (FA) | | | Posted | | Count of Participants | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number (%) of Patients With Presence of Subretinal Fluid (SRF), Intraretinal Fluid (IRF) in the Study Eye | To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters | Full Analysis Set- last observation carried forward (FAS - LOCF) | Posted | | Count of Participants | | Participants | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number of Patients With Presence of Subretinal Fluid (SRF) in the Study at Each Assessment Visit | Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit | | Posted | | Count of Participants | | Participants | | Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Number of Patients With Presence of Intraretinal Fluid (IRF) in the Study at Each Assessment Visit | Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit | | Posted | | Count of Participants | | Participants | | Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Intraretinal Fluid (IRF) Status in the Central Subfield: Proportion of Subjects With Presence of IRF in the Study Eye by Visit | Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit | | Posted | | Count of Participants | | Participants | | Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Count of Participants | | Participants | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Number | | Percentage estimates | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Count of Participants | | Participants | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Number | | Percentage estimates | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Count of Participants | | Participants | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Number | | Percentage estimates | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Count of Participants | | Participants | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | FAS - LOCF. For subjects with an assessment of the criterion. | Posted | | Number | | Percentage estimates | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Overall Score | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
| |
| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Near Activities | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Mental Health | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Dependency | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Driving | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Color Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Full Analysis Set - Observed | Posted | | Mean | Standard Deviation | Scores on a Scale | | Baseline, Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Brolucizumab Serum Concentration | To confirm the systemic brolucizumab exposure in a subset of patients. | Safety Set. Patients in the Safety set with a valid value for the outcome measure. Analysis for Weeks 4, 12, 24, 36 and 52 were below the level of quantification (BLQ). | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Approximately 24 hours post Day 1 treatment and approximately 24 hours post Week 24 treatment | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Number (%) of Patients Who Have Positive Anti-drug Antibody (ADA) Status in Brolucizumab Arm | To assess the immunogenicity of brolucizumab | Safety Set. Patients in the Safety set with a valid value for the outcome measure. | Posted | | Count of Participants | | Participants | | Up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject | | Posted | | Count of Participants | | Participants | | Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Secondary | Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject | | Posted | | Count of Participants | | Participants | | Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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| Post-Hoc | All Collected Deaths | On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to a maximum timeframe of approximately 52 weeks. Post-treatment deaths are reported for the timeframe of greater than 30 days after last treatment, until study completion, up to Week 52. All deaths refer to the sum of on-treatment and post-treatment deaths. | | Posted | | Count of Participants | | Participants | | On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, until study completion, up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Brolucizumab 6 mg | 5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance | | OG001 | Aflibercept 2 mg | 5 x every 4 weeks loading then every 8 weeks maintenance |
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