Phase 1 Study to Evaluate Safety and Tolerability of Eye Injections of Pozelimab in Adults with Geographic Atrophy from Age-Related Macular Degeneration

What this Trial Is About

Researchers are studying an experimental drug called pozelimab, given as an injection into the eye, for people with geographic atrophy GA, a condition where parts of the retina gradually stop working and vision worsens. The study aims to assess how safe and tolerable pozelimab is when used in this way. It also looks at side effects, how the drug moves through the blood and eye fluid, and whether the body produces antibodies that might affect the drugs action. Participants will receive intravitreal injections of pozelimab according to the study protocol. The study is organized in parts, with dose escalation and repeated doses being evaluated. Participants are randomly assigned in a quadruple-masked way to receive treatment. The study focuses on adults aged 50 years and older with GA linked to age-related macular degeneration AMD. During the trial, participants will have their vision tested and eye health monitored through visual acuity measures and assessments of adverse events in the eyes and body. Blood and eye fluid samples will be collected to measure drug levels and antibody responses up to 16 weeks. The main safety outcomes involve tracking treatment-emergent adverse events in the study eye and systemically during the 8 and 16 week periods. The total participation duration can last up to 16 weeks with regular evaluations.

Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants