NCT05984927

NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration

A Phase 1/2a Open-label Study to Evaluate Safety, Tolerability and Preliminary Efficacy of NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Elisigen, Inc. · Industry
• Sex: All
• Age: 50 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and preliminary efficacy of NG101 AAV gene therapy administered by subretinal injections into a single selected eye as a single selected dose for patients with wet age-related macular degeneration (wAMD).

Detailed description

This is a Phase 1/2a, multicenter, open-label, dose escalation study to evaluate the safety, tolerability, and preliminary efficacy of NG101 AAV gene therapy, administered by subretinal injection in patients with active wAMD symptoms. The study will be conducted at approximately 5 sites in Canada and the USA.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
GENETIC	NG101 AAV gene therapy	Sub retinal injection of NG101 (a non-replicating adeno-associated virus serotype 8 (AAV8) vector

Timeline

• Start date: 2023-09-08
• Primary completion: 2026-01-01
• Completion: 2030-01-01
• First posted: 2023-08-09
• Last updated: 2026-01-20

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study