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).
Male or female, aged ≥50 years old;
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;
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;
Sequential
EXG202
Biological/VaccineEXG202 is a gene therapy product for the treatment of wet (neovascular) age-related macular degeneration（wAMD） with a single intravitreal injection and administration.
Safety and tolerability after EXG202 injection
Frequency, type, and intensity of ocular and non-ocular Adverse Events (AEs) and serious adverse events (SAE) at Week 52, to explore the maximum tolerated dose (MTD)
To evaluate the efficacy after EXG202 injection
the Best Corrected Visual Acuity (BCVA) change from baseline
To evaluate the efficacy after EXG202 injection
The optical coherence tomography (OCT ).
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This trial is not recruiting at the moment. You can still explore other options:
