Actively Recruiting
An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Diabetic Macular Edema (DME)
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-10
32
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
I
Innostellar Biotherapeutics Co.,Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of LX111 gene therapy in adults with diabetic macular edema (DME), a condition causing swelling in the retina due to diabetes. This early-phase, prospective, multicenter trial aims to understand how well LX111 works and how safe it is for participants with DME. The study is divided into two parts: dose confirmation and dose expansion, to carefully assess different dosing levels. Participants will receive a single injection of LX111 into one eye at the start of the study. The gene therapy uses an rAAV vector carrying a VEGF-trap coding sequence designed to target the disease process. The trial includes several groups receiving different doses, including dose escalation and dose expansion phases, all involving one injection on Day 0. Throughout the study, participants will be monitored for any adverse events in their eyes and overall health for up to 52 weeks. Researchers will assess vision changes using best corrected visual acuity (BCVA) and measure retinal thickness at multiple time points. The need for additional anti-VEGF treatments and changes in diabetic retinopathy severity will also be tracked. Participants will attend follow-up visits for evaluations and safety checks during this one-year period.
CONDITIONS
Brief Title
Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent and attend follow-up visits
- Age 18 years or older
- Diagnosed with Type 1 or Type 2 diabetes with macular thickening due to diabetic macular edema involving the center of the fovea
- Central subfield thickness (CST) of 300 micrometers or more in the study eye at screening
- Best corrected visual acuity (BCVA) ETDRS letters between 19 and 73
- Received anti-VEGF therapy within 12 months prior to screening with a meaningful response
- Fertile male participants whose partners agree to contraception or fertile female participants agreeing to effective contraception from screening until last follow-up
You will not qualify if you...
- Active proliferative diabetic retinopathy (PDR)
- Iris neovascularization in the study eye at screening
- Retinal laser photocoagulation in the study eye within 3 months before screening
- Prior gene therapy in the study eye
- Intravitreal dexamethasone implant treatment in the study eye within 6 months before screening
- Systemic anti-VEGF treatment within 3 months before screening
- Received any investigational drug, agent, device, or therapy (ocular or non-ocular) within 3 months or at least 5 half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive a single unilateral intravitreal injection of LX111 gene therapy.
1 treatment visit (in-person)
Duration - Up to 52 weeks
Participants are monitored for safety and efficacy for up to 52 weeks after treatment.
Multiple follow-up visits over 52 weeks
Trial Site Locations
Total: 2 locations
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
2
Zhongshan Hospital
Shanghai, China
Not Yet Recruiting
Research Team
L
Li Su
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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