An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Diabetic Macular Edema (DME)
The goal of this study is to evaluate the safety and efficacy of LX111 treatment of DME. This study will enroll participants aged ≥ 18 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.
• Willing to sign the informed consent, and willing to attend follow-up visits;
• Age ≥ 18;
• Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;
• CST ≥ 300 μm in the study eye at Screening;
• BCVA ETDRS letters between 19 and 73;
• Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response;
• Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.