NCT07362927

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)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
GENETIC	LX111 Injection	LX111 is an rAAV gene therapy vector carrying a coding sequence for VEGF-trap.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2031-09-01
• First posted: 2026-01-23
• Last updated: 2026-03-10

Locations

2 sites across 1 country: China