A Randomized Double-masked, Multicenter, 3-arm, Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE201/MK-8748 Compared to Aflibercept (2 mg) in Participants With Neovascular Age-related Macular Degeneration

What this Trial Is About

Researchers are investigating new treatments for neovascular age-related macular degeneration (NVAMD), a condition where current standard treatments like aflibercept do not work for everyone. This trial aims to find out if a medicine called tiespectus (also known as MK-8748 or EYE201) can treat NVAMD as well as aflibercept. The study is a pivotal Phase 2/3 trial designed to compare the effectiveness and safety of these treatments. Participants are randomly assigned to one of three groups: one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. The tiespectus groups receive three initial injections every 4 weeks, then injections every 8 weeks until week 48, followed by treatment based on individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks up to week 92. During the study, participants will have their vision tested to measure changes in best-corrected visual acuity using ETDRS letters from baseline to one year. Other assessments include optical coherence tomography scans to measure retinal thickness and monitoring for any eye or systemic side effects. The study lasts up to approximately 92 weeks to evaluate treatment effects and safety over time.

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)