Clinical Trial

Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients

Recruiting Early Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-15.
Status change: Not Yet Recruiting → Recruiting 2026-03-09
Trial Details
NCT Number NCT07362927
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators: Innostellar Biotherapeutics Co.,Ltd
Conditions Diabetic Macular Edema (DME)
Enrollment 32 participants
Start Date 2026-03
Primary Completion 2027-09 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-10