NCT07178249

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

A Phase I/II Clinical Study Evaluating the Safety and Preliminary Efficacy of EXG202 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou Jiayin Biotech Ltd · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	EXG202 injection	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.

Timeline

• Start date: 2025-10-16
• Primary completion: 2028-02-28
• Completion: 2032-12-30
• First posted: 2025-09-17
• Last updated: 2025-09-17