RRG001: Administered via Subretinal injection. Dosage form: injection solution.
Study 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
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety and tolerability — Week 52 incidence of AEs and SAEs
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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