Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

• Status: Recruiting
• Trial end date: 2030-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RRG001 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.RRG001 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Refreshgene Technology Co., Ltd.

Criteria

Inclusion Criteria:

• Subjects that are willing and able to follow study procedures.

• Patinets ≥50 years old.

• Clinically diagnosed with CNV secondary to nAMD.

• BCVA of the study eye is ≥5 letters and ≤73 letters(Snellen 20/800~20/40), as well as that of the other eye ≥19 letters(Snellen 20/400).

• Responding to anti-VEGF

Exclusion Criteria:

• Presence of any other eye diseases other than nAMD in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator.

• CNV or macular edema in the study eye secondary to any causes other than AMD.

• Uncontrolled glaucoma.

• Uncontrolled hypertension despite medication.

• Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.