Evaluating the Safety and Preliminary Efficacy of EXG202 Gene Therapy for Neovascular AMD

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorGuangzhou Jiayin Biotech Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • EXG202 injection

Treatment groups

60 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators