Phase II Study of Intravitreal IBI302 Injection for Treating Neovascular Age-related Macular Degeneration in Adults 50 and Older

What this Trial Is About

Researchers are evaluating the safety and effectiveness of IBI302 given by intravitreal injection in patients with neovascular age-related macular degeneration nAMD. This open-label, multicenter, single-arm Phase II trial focuses on people aged 50 and older who have active choroidal neovascularization affecting the macular fovea. The study aims to understand how well visual acuity is preserved over time with this treatment. Participants will receive an 8 mg dose of IBI302 injected into the study eye once every 4 weeks for the first 3 months, followed by injections every 8 weeks thereafter. This treatment schedule is designed to assess the drugs impact over a 52-week period. The trial does not include a comparison or placebo group and involves a single treatment arm. During the study, participants will have their best corrected visual acuity BCVA tested regularly, along with eye imaging using OCT and fundus fluorescein angiography to monitor changes in the retina and choroidal neovascularization. Researchers will also track adverse events and the development of anti-drug antibodies. The main outcome is the proportion of participants whose BCVA decreases by less than 15 letters from baseline at week 52. Follow-up assessments will occur at multiple visits throughout the year-long study.

A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD