An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Diabetic Macular Edema (DME)

NCT07362927 EARLY_PHASE1 RECRUITING

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.

Details

Lead sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	32
Start date	2026-03
Completion	2031-09

Conditions

• Diabetic Macular Edema (DME)

Interventions

• LX111 Injection

Primary outcomes

• Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment — 52 weeks
  Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.
• Dose Limiting Toxicity — 4 weeks
  The incidence of DLT in each dose group.

Countries

China