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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Sequential
Treatments tested in this trial
RRG001
DrugAdministered via Subretinal injection. Dosage form: injection solution.
Treatment groups
Trial outcomes
Primary outcomes
Safety and tolerability
incidence of AEs and SAEs
Secondary outcomes
Efficacy after RRG001 injection
change in best-corrected visual acuity (BCVA);
Efficacy after RRG001 injection
change in central retinal thickness (CRT)
Sponsors and contacts
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