Palm Desert

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating two treatment strategies for neovascular age-related macular degeneration (nAMD), a condition that affects vision in people aged 50 and older. This Phase 3 trial compares a standard "Treat and Extend" (T&E) dosing schedule of anti-vascular endothelial growth factor therapy with a newer approach guided by home optical coherence tomography (OCT) imaging. The study aims to find out if daily home OCT monitoring can improve visual acuity outcomes and reduce the number of injections needed over a period of 104 weeks compared to the standard T&E approach. Participants receive intravitreal injections of 6 mg faricimab, either on a Treat and Extend schedule or guided by daily home OCT scans. At baseline, participants undergo vision tests, ocular exams, and imaging, followed by a faricimab injection. Those eligible for randomization are assigned to one of the two treatment groups. The T&E group returns for office visits every 4 to 18 weeks, while the home OCT group performs daily self-scans and only visits the clinic if fluid above a certain threshold is detected. The study follows participants for 104 weeks, with key visits at 52 and 104 weeks. Participants are involved in daily home OCT scanning if assigned to that group, attend scheduled visits for vision and imaging assessments, and undergo monitoring for treatment response and safety. Researchers measure changes in visual acuity using the E-ETDRS letter score and count the number of faricimab injections over the two-year period. The study also assesses adherence to daily scanning and evaluates treatment burden and outcomes for each approach to managing nAMD.