Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in best-corrected visual acuity (BCVA) |
To demonstrate that brolucizumab is non-inferior to aflibercept with respect to the visual outcome |
Baseline to Week 52 |
|
| Secondary |
Average change in BCVA |
To demonstrate that brolucizumab is non-inferior to aflibercept with respect to the visual outcome |
Baseline, over period Week 40 to Week 52 |
|
| Secondary |
Proportion of patients maintained treatment regimen of every 12 weeks in brolucizumab arm |
To estimate the proportion of patients treated at every 12 weeks (q12w) frequency with brolucizumab |
Baseline up to Week 52 |
|
| Secondary |
Proportion of patients maintained dosing regimen of every 12 weeks (q12w) interval up to Week 52, within those patients that qualified for q12w at dosing regimen at Week 36 |
To estimate the predictive value of the first q12w cycle for maintenance of q12w treatment with brolucizumab |
Up to Week 52 |
|
| Secondary |
Change in BCVA |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period |
Baseline up to Week 52 |
|
| Secondary |
Average change in BCVA |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period |
Baseline up to Week 52, over period Week 20 to Week 52, Period Week 28 to Week 52 |
|
| Secondary |
Proportion of patients who gain in BCVA of =5, =10 and =15 ETDRS letters from baseline to each post-baseline visit |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period |
Baseline up to Week 52 |
|
| Secondary |
Time to achieve gain of =5, =10 and =15 ETDRS letters from baseline (or reaching a score of 84 or more) |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period |
Baseline up to Week 52 |
|
| Secondary |
Proportion of patients who loss in BCVA of =5, =10 and =15 ETDRS letters from baseline to each post-baseline visit |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period |
Baseline up to Week 52 |
|
| Secondary |
Proportion of patients who have absolute BCVA =73 ETDRS letters at each post-baseline visit |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period |
Baseline up to Week 52 |
|
| Secondary |
Proportion of patients need q8w treatment |
To evaluate the efficacy related to dosing regimen of brolucizumab |
Week 32 |
|
| Secondary |
Proportion of patients with per planned dosing regimen (q8w or q12w) |
To evaluate the efficacy related to dosing regimen |
Week 52 |
|
| Secondary |
Change in Central Subfield Thickness (CSFT) at each assessment visit |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters |
Baseline up to Week 52 |
|
| Secondary |
Average change in CSFT |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters |
Baseline, over period of Week 4 to Week 52, over period of Week 40 to Week 52 |
|
| Secondary |
Proportion of patient who have normal CSFT (<280 microns) at each assessment visit |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters |
Baseline up to Week 52 |
|
| Secondary |
Change in Central Subfield Thickness-neurosensory retina (CSFTns) at each assessment visit |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters |
Baseline up to Week 52 |
|
| Secondary |
Average change in CSFTns |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters |
Baseline, over the period of Week 4 to Week 52, over period of Week 40 to Week 52 |
|
| Secondary |
Proportion of patients with presence of subretinal fluid (SRF), Intraretinal fluid (IRF) and simultaneous absence of SRF and IRF at each assessment visit |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters |
Baseline up to Week 52 |
|
| Secondary |
Proportion of patients with presence of leakage on fluorescein angiography (FA) |
To evaluate the efficacy of brolucizumab relative to aflibercept over the time period by assessing changes in anatomical parameters |
Week 52 |
|
| Secondary |
Change from baseline in ETDRS Diabetic Retinopathy Severity Scale score at each assessment visit |
To evaluate the efficacy of brolucizumab relative to aflibercept on the Diabetic Retinopathy status |
Baseline up to Week 52 |
|
| Secondary |
Number of patients with progression to proliferative diabetic retinopathy (PDR) as assessed by ETDRS-DRSS Score of at least 61 by Week 52 |
To evaluate the efficacy of brolucizumab relative to aflibercept on the Diabetic Retinopathy status |
Week 52 |
|
| Secondary |
Change in patient reported outcomes (Visual Function Questionnaire-25) total and subscale scores |
To assess visual function-related patient reported outcomes (VFQ-25) following treatment with brolucizumab relative to aflibercept. The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score will be calculated by averaging vision-targeted subscale scores, excluding the general health rating question. |
Baseline up to Week 28 and Week 52 |
|
| Secondary |
Systemic brolucizumab concentration |
To confirm the systemic brolucizumab exposure in a subset of patients. |
Approximately 24 hours post Day 1 treatment and approximately 24 hours post Week 24 treatment |
|
| Secondary |
Proportion of patients who have positive anti-drug antibody status in brolucizumab arm |
To assess the immunogenicity of brolucizumab |
At Screening, Week 4, 12, 24, 36, and 52 (End of Study) |
|
