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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCTID
NCT06141460
(View at clinicaltrials.gov)
Description
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
(Show More)
Development Status
Active
Indication
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term
DOID:10871
Compound Name
RRG001
Sponsor
Shanghai Refreshgene Technology Co., Ltd.
Funder Type
Industry
Recruitment Status
Recruiting
Enrollment Count
48
Results Posted
Not Available
Therapy Information
Target Gene/Variant
Anti-VEGF
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Genetic delivery of therapeutic protein
Route of Administration
Subretinal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV
Editor Type
none
Dose 1
Undisclosed dose 1
Dose 2
Undisclosed dose 2
Dose 3
Undisclosed dose 3
Dose 4
Undisclosed dose 4
Dose 5
Dose range: 1E8 - 1E13 vg/eye
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2023-11-10
Completion Date
2030-12-31
Last Update
2024-11-14
Participation Criteria
Eligible Age
>=50 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
1
Locations
China
Regulatory Information
Has US IND
False
FDA Designations
Recent Updates
Resources/Links