NCT06141460RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 10 Nov 2023
- Start date
- 12 Dec 2023
- Primary completion date
- 15 Apr 2026
- Lead sponsor
- Shanghai Refreshgene Technology Co., Ltd.
- Diseases
- Macular degeneration
- NCT number
- NCT06141460
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 48
- From 12 Dec 2023 to the primary completion date, 15 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Uncontrolled hypertension despite medication.
Other
- CNV or macular edema in the study eye secondary to any causes other than AMD.
- Uncontrolled glaucoma.
- Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Eye Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.