A Dose-escalation and Dose-expanded Phase I/II Study to Evaluate Safety and Efficacy of FT-003 Gene Therapy in People With Wet Age-related Macular Degeneration

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of FT-003, a gene therapy for people with neovascular age-related macular degeneration (nAMD), a leading cause of blindness in older adults. The study includes two phases: Phase 1 dose escalation and Phase 2 dose expansion. FT-003 aims to provide long-lasting treatment by delivering therapeutic protein levels inside the eye, potentially reducing the need for frequent injections required by current therapies. Participants receive one of three doses of FT-003 through an injection into the eye. The study is designed to test low, mid, and high doses to find the best balance of safety and effect. This approach may help reduce the treatment burden and prevent vision loss caused by undertreatment in people with nAMD. During the study, participants will be closely monitored for safety and tolerability up to 12 weeks after the injection, with efficacy assessed at 24 weeks. Researchers will track vision changes, eye health, and any side effects. Participants will undergo regular eye exams and vision tests to evaluate the therapy's impact over the course of the study, which runs until October 2028.

Gene Therapy(FT-003) for Wet AMD