Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients

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.

This trial is a prospective, multicenter, dose-ranging trial to evaluate the safety and efficacy of LX111 in participants with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.

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;