Study of SKG0106 Gene Therapy Injection to Treat Neovascular Age-related Macular Degeneration in Patients 50 and Older

What this Trial Is About

Researchers are evaluating the safety, early effectiveness, immune response, and how the body processes SKG0106 in people with neovascular age-related macular degeneration nAMD. This study is an open-label, dose-escalation clinical trial aimed at assessing these factors after a single intravitreal injection of SKG0106, a gene therapy product, in Chinese patients aged 50 and older who have this eye condition. Participants receive one of three different dose levels of SKG0106 through a single injection into the eye. The study is non-randomized and open-label, meaning both researchers and participants know which dose is given. The trial focuses on evaluating dose-limiting toxicities within 4 weeks and tracking ocular and systemic adverse events over 48 weeks. During the study, participants will have their vision tested using best corrected visual acuity assessments and their eye structure examined by imaging techniques such as spectral domain optical coherence tomography. Patient-reported outcomes about vision quality will also be collected. These evaluations occur at regular visits up to 48 weeks to monitor safety, visual changes, and quality of life after treatment with SKG0106.

A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)