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Clinical Trials in China / NCT06141460
Recruiting Phase 1/2

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

NCT06141460 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Refreshgene Technology Co., Ltd.
Phase
Phase 1/2
Started
2023-12-12
Last updated
2024-11-14

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

RRG001

RRG001: Administered via Subretinal injection. Dosage form: injection solution.

Study 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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Eye Hospital Tianjin Tianjin Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06141460 on ClinicalTrials.gov ↗ ← All trials in China