Long-term Observational Follow-Up Study to Evaluate SKG0106 in Treating Patients with Wet Age-related Macular Degeneration

What this Trial Is About

This research aims to observe patients with neovascular wet age-related macular degeneration nAMD who have previously been treated with SKG0106. The study is prospective, non-interventional, and multicenter, focusing on long-term follow-up to evaluate the safety and effects of SKG0106 over a period of up to 5 years after the initial treatment. It includes participants who completed earlier clinical studies involving this treatment. No new study drug or intervention will be administered during this follow-up. Instead, participants will be monitored for safety and efficacy outcomes related to their prior SKG0106 injections at different dose levels. The study groups correspond to participants exposed to three different SKG0106 dose levels, but all receive observational follow-up without additional treatment. Participants will undergo regular assessments to monitor ocular and systemic adverse events, including serious and special interest events, over the 5-year period. Evaluations will also include changes in best corrected visual acuity, macular central subfield thickness, and patient-reported visual function scores. This long-term monitoring aims to provide comprehensive safety and effectiveness data while participants continue their usual care.

A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD