VEGF inhibitors (anti-VEGF),such as aflibercept has been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients.
EXG 202 is a recombinant adeno-associated virus (rAAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available therapies while maintaining vision with a favorable benefit.
Male or female, aged ≥50 years old;
The study eye must be diagnosed of wAMD and current active lesions;
Subjects have 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 ;
The study eye has a history of retinal detachment or retinal detachment during the screening period;
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;
Any intraocular surgery is planned for the study eye during the study period;
Sequential
EXG202 injection
Biological/VaccineEXG202 injection 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
Type, severity, and incidence of adverse events (AEs) and serious adverse events (SAEs) from Week 0 to 52, and dose limited toxicity
Preliminary Efficancy after EXG202 injection
The Best Corrected Visual Acuity (BCVA) change from baseline
Safety and tolerability after EXG202 injection
Type, severity, and incidence of adverse events (AEs) and serious adverse events (SAEs) from Week 0 to 24, and dose limited toxicity
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