A Randomized, Double-Masked, Multicenter Study Comparing the Safety and Effectiveness of Intravitreal EYE201MK-8748 Tiespectus to Aflibercept in People with Neovascular Age-Related Macular Degeneration

What this Trial Is About

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a form of wet macular degeneration. This study aims to find out if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as effectively as the current standard treatment, aflibercept. The trial is a pivotal Phase 23 study comparing these treatments in people with this eye condition. Participants will be randomly assigned to one of three groups one receiving a low dose of tiespectus, another receiving a high dose of tiespectus, and a third group receiving aflibercept. The tiespectus groups start with three injections every four weeks, then continue with injections every eight weeks until week 48. After this, the treatment schedule is personalized up to week 92. The aflibercept group also receives three initial injections followed by injections every eight weeks until week 92. During the study, participants will have their vision assessed using best-corrected visual acuity BCVA and other eye measurements at baseline and through one year. Researchers will monitor changes in vision, eye thickness, and any side effects. The entire study period includes treatment and follow-up visits up to approximately 92 weeks, allowing detailed observation of treatment effects and safety over time.

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)