Actively Recruiting
Phase 3 Study of a Single Eye Injection of 4D-150 for Adults With Macular Neovascularization Caused by Age-Related Macular Degeneration
Led by 4D Molecular Therapeutics · Updated on 2026-04-16
480
Participants Needed
94
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a single intravitreal injection of 4D-150 in adults aged 50 and older with macular neovascularization caused by neovascular age-related macular degeneration nAMD. This Phase 3 trial compares 4D-150 to an active control treatment, aflibercept, to better understand how these treatments affect vision and eye health in this condition. Participants are randomly assigned to receive either one dose of 4D-150 or aflibercept injections at scheduled visits. The 4D-150 is given as a single intravitreal injection on Day 1, while aflibercept is administered during follow-up visits as needed. The study includes a 52-week period to assess visual changes and a longer 104-week period to monitor the need for additional aflibercept injections and other eye health measures. During the study, participants will undergo eye exams including measurements of visual acuity using the ETDRS letter score and evaluations of the central subfield thickness in the retina. Researchers will track the number and timing of aflibercept injections and monitor any anatomical or functional changes in the treated eye. Safety and stability of vision will be observed throughout the trial period, which lasts up to two years.
CONDITIONS
Brief Title
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Research Team
4
4DMT Patient Advocacy
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