RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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.
Treatments Being Tested
DRUG
RRG001
Administered via Subretinal injection. Dosage form: injection solution.
Locations (1)
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China