Tests LX111 gene therapy in adults with diabetic macular edema
Tests LX111, a gene therapy injected into the eye, in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
Key facts
- Where
- Shanghai, ChinaSee the 2 sites
- Phase
- Early phase 1
Where in China
- Shanghai General HospitalShanghai, ChinaTaking people
- Zhongshan HospitalShanghai, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Trial code
- NCT07362927
- Record updated
- 10 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Willing to sign the informed consent, and willing to attend follow-up visits; Age ≥ 18; Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; CST ≥ 300 μm in the study eye at Screening; BCVA ETDRS letters between 19 and 73; Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response; 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: Retinal laser photocoagulation in the study eye within 3 months prior to Screening; Prior gene therapy in the study eye; The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening; Systemic anti-VEGF treatment within 3 months before Screening; 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; Active proliferative diabetic retinopathy (PDR); Presence of iris neovascularization in the study eye at Screening.