Phase 2 Study to Assess the Safety and Effectiveness of ONL1204 Eye Injections for Geographic Atrophy Linked to Age-Related Macular Degeneration in Adults 55 and Older

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intravitreal injections of ONL1204 in patients who have geographic atrophy GA associated with age-related macular degeneration AMD. GA linked to AMD is a leading cause of vision loss and legal blindness worldwide, affected by factors such as aging, smoking, obesity, diet, cardiac risk lifestyle, and genetics. ONL1204 is a new type of drug designed to protect retinal cells by inhibiting a pathway that causes cell death, previously showing promise in preclinical retinal disease models. The study includes several experimental groups receiving different doses and frequencies of ONL1204 injections into the eye, including 100 or 200 micrograms every 12 weeks or 200 micrograms every 24 weeks. There are also comparison groups receiving sham injections every 12 or 24 weeks and an active comparator group receiving monthly injections of avacincaptad pegol. These treatments are given by intravitreal injection over a 48-week treatment period. Participants will attend regular study visits for up to 48 weeks, during which researchers will monitor safety and effectiveness through visual acuity tests and imaging of the retina. The primary outcome is measured from enrollment to the end of treatment at 48 weeks. Safety assessments will also be conducted throughout the study. Participants must meet specific eye health criteria and will be closely monitored for any adverse effects or changes in their condition during the study.

Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD