RecruitingPhase 1Phase 2NCT06141460

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

A Phase I/IIa, Dose-escalation and Dose-extension Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration

Sponsor

Shanghai Refreshgene Technology Co., Ltd.

Enrollment

48 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

Neovascular Age-related Macular Degeneration

Summary

A Phase I/IIa, Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration

Eligibility

Min Age: 50 Years

Inclusion Criteria5

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 Criteria5

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.

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