Status:
RECRUITING
Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Lead Sponsor:
Shanghai Refreshgene Technology Co., Ltd.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief 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
Detailed Description
This study adopts a multicenter, single-arm, open-label phase I/IIa seamless study design and comprises two stages, i.e., phase I 3+3 dose escalation study and a phase IIa dose expansion study. Four d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06141460
Start Date
December 12 2023
End Date
December 31 2030
Last Update
November 14 2024
Active Locations (1)
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1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300384