Status:
NOT_YET_RECRUITING
To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)
Lead Sponsor:
Hangzhou Jiayin Biotech Ltd
Conditions:
Wet Age-related Macular Degeneration (wAMD)
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).
Detailed Description
EXG 202 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The avai...
Eligibility Criteria
Inclusion
- Male or female, aged ≥50 years old;
- The study eye must meet the following criteria:
- A. Diagnosed of wAMD and current active lesions; active, defined as the presence of any of the following lesions in the macular area upon OCT examination: a) intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. The BCVA score tested during screening using the ETDRS eye chart (see Appendix 3 for details) must be between 73-19 letters (including boundary values), (equivalent to Snellen visual acuity of 20/40 to 20/400);
- Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.
- The subject has clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;
- Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;
- Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; have good compliance and are willing to abide by the research procedures.
Exclusion
- The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection (such as macular hole, macular epiretinal membrane, etc.);
- The study eye has a history of retinal detachment or retinal detachment during the screening period (such as rhegmatogenous retinal detachment, tractional retinal detachment, etc.);
- The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;
- The study eye plans to undergo any intraocular surgery during the study period;
Key Trial Info
Start Date :
March 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06888492
Start Date
March 28 2025
End Date
April 30 2026
Last Update
March 21 2025
Active Locations (2)
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1
Hebei Eye Hospital
Xingtai, Hebei, China, 054001
2
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China, 322000