Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients

Inclusion Criteria: 1. Willing to sign the informed consent, and willing to attend follow-up visits; 2. Age ≥ 18; 3. Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; 4. CST ≥ 300 μm in the study eye at Screening; 5. BCVA ETDRS letters between 19 and 73; 6. Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response; 7. 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. Exclusion Criteria: 1. Active proliferative diabetic retinopathy (PDR); 2. Presence of iris neovascularization in the study eye at Screening; 3. Retinal laser photocoagulation in the study eye within 3 months prior to Screening; 4. Prior gene therapy in the study eye; 5. The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening. 6. Systemic anti-VEGF treatment within 3 months before Screening; 7. Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to Screening;