NCT07362927RecruitingEarly phase 1
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)
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- Mar 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Diabetic eye disease
- NCT number
- NCT07362927
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 32
- From Mar 2026 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- Active proliferative diabetic retinopathy (PDR);
- Presence of iris neovascularization in the study eye at Screening;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.