Actively Recruiting
Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-10
10
Participants Needed
1
Research Sites
234 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 nAMD. This study will enroll subjects aged ≥ 50 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 nAMD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent and attend follow-up visits
- Age 50 years or older
- Diagnosed with active choroidal neovascularization secondary to neovascular age-related macular degeneration
- Best corrected visual acuity (BCVA) ETDRS letters between 5 and 63
- Received at least 2 anti-VEGF injections within 6 months before screening and showed meaningful response
- Fertile males with fertile female partners or fertile females agree to use effective contraception from screening until last follow-up
You will not qualify if you...
- CNV or macular edema in the study eye caused by diseases other than neovascular age-related macular degeneration
- Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing vision improvement
- Acute coronary syndrome, myocardial infarction, coronary artery revascularization, cerebrovascular accident (CVA), or transient ischemic attack (TIA) in the last 6 months
- Uncontrolled hypertension with average systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
- Uncontrolled diabetes with HbA1c greater than 8.0% within 28 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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