Actively Recruiting
Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-10
32
Participants Needed
2
Research Sites
287 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
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.
CONDITIONS
Official 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 informed consent and attend follow-up visits
- Age 18 years or older
- Diagnosed with Type 1 or Type 2 diabetes with macular thickening involving the center of the fovea due to DME
- Central subfield thickness (CST) of 300 micrometers or more in the study eye at screening
- Best corrected visual acuity (BCVA) between 19 and 73 ETDRS letters
- Received anti-VEGF therapy within 12 months prior to screening and showed meaningful response
- Fertile male participants with fertile female partners or fertile female participants agree to use effective contraception from screening until last follow-up
You will not qualify if you...
- Active proliferative diabetic retinopathy
- 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 prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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