Palm Desert

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

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.