Effectiveness and Safety of ABP 938 in Patients With Neovascular Age-related Macular Degeneration [Neovascular(Wet)AMD]

Effectiveness and Safety of ABP 938 in Patients With Neovascular Age-related Macular Degeneration [Neovascular(Wet)AMD]

Brief Summary:
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.

Detailed Description:
Approximately 566 subjects will be randomized in approximately 116 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:
- Subjects initially randomized to ABP 938 (Treatment Group A) will continue to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48
- Subjects initially randomized to aflibercept (Treatment Group B) will be re-randomized in a 1:1 ratio to either continue on aflibercept (Treatment Group B1) or transition to ABP 938 (Treatment Group B2) by IVT injection every 8 weeks from week 16 until week 48


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The study is double-masked; therefore, the investigators, study personnel, and the study subjects will remain masked to treatment allocation. Unmasking is only allowed in the case of an emergency, when knowledge of the investigational product is essential for the clinical management of the subject.
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Phase 3 Study of ABP 938 Efficacy and Safety Compared to Aflibercept (Eylea®) in Subjects With Neovascular Age-related Macular Degeneration
Actual Study Start Date: June 22, 2020
Estimated Primary Completion Date: February 25, 2022
Estimated Study Completion Date: December 30, 2022

Arm:
- Experimental: ABP 938-Treatment Group A
- Active Comparator: Aflibercept-Treatment Group B
- Active Comparator: Aflibercept-Treatment Group B1
- Experimental: ABP 938-Treatment group B2

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