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Exploring the Safety and Effectiveness of LX111 Gene Therapy for Treating Diabetic Macular Edema
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-10
32
Participants Needed
2
Research Sites
208 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of LX111 gene therapy in adults with diabetic macular edema DME, a condition causing swelling in the retina due to diabetes. This early-phase, prospective, multicenter trial aims to understand how well LX111 works and how safe it is for participants with DME. The study is divided into two parts dose confirmation and dose expansion, to carefully assess different dosing levels. Participants will receive a single injection of LX111 into one eye at the start of the study. The gene therapy uses an rAAV vector carrying a VEGF-trap coding sequence designed to target the disease process. The trial includes several groups receiving different doses, including dose escalation and dose expansion phases, all involving one injection on Day 0. Throughout the study, participants will be monitored for any adverse events in their eyes and overall health for up to 52 weeks. Researchers will assess vision changes using best corrected visual acuity BCVA and measure retinal thickness at multiple time points. The need for additional anti-VEGF treatments and changes in diabetic retinopathy severity will also be tracked. Participants will attend follow-up visits for evaluations and safety checks during this one-year period.
CONDITIONS
Brief Title
Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
Research Team
L
Li Su
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