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.
This Phase I/II study was designed to evaluate the safety and Preliminary Efficacy of EXG202 gene therapy in subjects with nAMD. Subjects who met the inclusion/exclusion criteria and had response to an initial anti-VEGF injection received a single dose of EXG202 administered . Safety was the primary focus for the phase I/II trial ,at the same time ,preliminary Efficacy also is another goal for the trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
EXG202 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
Time frame: Up to 52 weeks after treatment
Preliminary Efficancy after EXG202 injection
The Best Corrected Visual Acuity (BCVA) change from baseline
Time frame: Up to 52 weeks after treatment
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
Time frame: Up to 24 weeks after treatment
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