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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Contact Information
Primary
Xiaorong Li, Master
xiaorong.li@163.com
8602223346434
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 48
Treatments
Experimental: RRG001 Dose1
Frequency of administration: one time injection.
Experimental: RRG001 Dose2
Frequency of administration: one time injection.
Experimental: RRG001 Dose3
Frequency of administration: one time injection.
Experimental: RRG001 Dose4
Frequency of administration: one time injection.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Refreshgene Technology Co., Ltd.