A Study to understand Effectiveness and Safety of ABP 938 compared to Aflibercept (Eylea®) in patients suffering with Neovascular Age-related Macular Degeneration [neovascular (wet) AMD]
Study Details
The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.
Protocol Summary
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Timeframe: At week 8
Change from Baseline in ETDRS letter score at week 52 maintaining vision lost fewer than 15 letters
Timeframe: At week 52
Change from Baseline in BCVA
Timeframe: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52
Change from Baseline in ETDRS letter score at week 8 and week 52
Timeframe: At week 8 and week 52
Change from Baseline in Choroidal Neovascularization (CNV) area
Timeframe: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52
Change from Baseline in Central Subfield Thickness (CST)
Timeframe: At screening, day 1, week 4, week 8, week 16, week 24, week 32, week 40, week 48 and week 52
Number of subjects with incidence of Antidrug Antibodies (ADA)
Timeframe: At day 1, week 8, week 16, week 24, week 40 and week 52
Number of subjects with treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events
Timeframe: Upto 56 weeks