NCT07362927 Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
| NCT ID | NCT07362927 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Diabetic Macular Edema (DME) |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-03 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-03 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Willing to sign the informed consent, and willing to attend follow-up visits; 2. Age ≥ 18; 3. Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; 4. CST ≥ 300 μm in the study eye at Screening; 5. BCVA ETDRS letters between 19 and 73; 6. Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response; 7. 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 Criteria: 1. Active proliferative diabetic retinopathy (PDR); 2. Presence of iris neovascularization in the study eye at Screening; 3. Retinal laser photocoagulation in the study eye within 3 months prior to Screening; 4. Prior gene therapy in the study eye; 5. The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening. 6. Systemic anti-VEGF treatment within 3 months before Screening; 7. 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07362927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema (DME). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07362927 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07362927 currently recruiting?
Yes, NCT07362927 is actively recruiting participants. Contact the research team at li.su@shgh.cn for enrollment information.
Where is the NCT07362927 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07362927 clinical trial?
NCT07362927 is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 32 participants.