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
Approximately 566 subjects will be randomized in approximately 126 global sites.
This study consists of a screening period of up to 4 weeks, after which subjects will receive investigational product for 48 weeks, followed by a safety follow-up period to week 52, for a total study duration of up to 56 weeks.
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 IVT injection.
At week 8, subjects will be assessed for the primary endpoint. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline to week 8, in order to assess the efficacy of ABP 938 compared to aflibercept.
Subjects will then be re-randomized at week 16 in a masked fashion such that:
| Condition | Neovascular (Wet) Age-related Macular Degeneration (AMD) |
|---|---|
| Treatment | Aflibercept, ABP 938 |
| Clinical Study Identifier | NCT04270747 |
| Sponsor | Amgen |
| Last Modified on | 5 March 2022 |
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