A Phase III, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Subretinal Injection of LX102 in Participants With Neovascular Age-Related Macular Degeneration - The STELLAR Trial
This is a Phase III, randomized, open-label, active-controlled study to evaluate the efficacy and safety of subretinal injection of LX102 in participants with neovascular age-related macular degeneration. The study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks 48 and 56.
• Willing and able to provide written, signed informed consent for this study;
• Age ≥50 and ≤80 years old;
• Active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
• The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;
• Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
• No anti-VEGF therapy in study eye within 28 days before screening;
• Must be pseudophakic in the study eye.