Phase 12 Study of SKG0106 Eye Injection to Treat Neovascular Age-related Macular Degeneration in Adults 50 and Older

What this Trial Is About

Researchers are conducting a phase 12 clinical trial to evaluate the safety, early effectiveness, immune response, and how the body processes SKG0106, a gene therapy, in adults with neovascular age-related macular degeneration nAMD. This study follows results from an earlier phase 1 dose escalation study and aims to further explore these factors in patients with this eye condition. Participants will receive a one-time injection of SKG0106 directly into the eye. The study includes three dose levels low, medium, and high. Each participant will receive only one dose. The trial is non-randomized and open-label, meaning all participants will know the treatment they receive. The study will monitor effects for up to 52 weeks after injection. During the study, participants will undergo eye exams and assessments to track visual acuity, retinal thickness, and patient-reported vision-related quality of life. Researchers will monitor safety by recording any eye-related or systemic side effects and any dose-limiting toxicities within the first 4 weeks. The total follow-up period for each participant is one year, during which changes in vision and safety outcomes will be closely observed.

Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)