Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
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
1 other identifier
interventional
48
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2023
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedStudy Start
First participant enrolled
December 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
ExpectedNovember 14, 2024
November 1, 2024
2.3 years
November 10, 2023
November 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
incidence of AEs and SAEs
Week 52
Secondary Outcomes (2)
Efficacy after RRG001 injection
Week 52
Efficacy after RRG001 injection
Week 52
Study Arms (4)
RRG001 Dose1
EXPERIMENTALFrequency of administration: one time injection.
RRG001 Dose2
EXPERIMENTALFrequency of administration: one time injection.
RRG001 Dose3
EXPERIMENTALFrequency of administration: one time injection.
RRG001 Dose4
EXPERIMENTALFrequency of administration: one time injection.
Interventions
Administered via Subretinal injection. Dosage form: injection solution.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2023
First Posted
November 21, 2023
Study Start
December 12, 2023
Primary Completion
April 15, 2026
Study Completion (Estimated)
December 31, 2030
Last Updated
November 14, 2024
Record last verified: 2024-11