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]
NCT04270747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576
Last updated 2025-09-10
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.
Conditions
- Neovascular (Wet) Age-related Macular Degeneration (AMD)
Interventions
- DRUG
-
ABP 938
Subject will receive ABP 938 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
- DRUG
-
Subject will receive aflibercept 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-22
- Primary Completion
- 2022-07-18
- Completion
- 2023-01-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- Czechia
- Estonia
- Germany
- Hong Kong
- Hungary
- Israel
- Italy
- Japan
- Latvia
- Lithuania
- Mexico
- Poland
- Serbia
- Slovakia
- South Korea
- Spain
Study Locations
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