Actively Recruiting
Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Led by Shanghai Refreshgene Technology Co., Ltd. · Updated on 2024-11-14
48
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to follow study procedures
- Age 50 years or older
- Clinically diagnosed with choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration
- Best corrected visual acuity (BCVA) of the study eye between 5 and 73 letters (Snellen 20/800 to 20/40)
- BCVA of the other eye 19 letters or better (Snellen 20/400)
- Responding to anti-vascular endothelial growth factor (anti-VEGF) treatment
You will not qualify if you...
- Presence of other eye diseases besides neovascular age-related macular degeneration in the study eye that could affect treatment or study results
- CNV or macular edema in the study eye caused by conditions other than age-related macular degeneration
- Uncontrolled glaucoma
- Uncontrolled hypertension despite medication
- Pregnant or lactating women or individuals with reproductive potential unwilling to use effective contraception during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300384
Actively Recruiting
Research Team
X
Xiaorong Li, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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