A Study to Compare GNR-139 and Eylea® in Patients With nAMD
This is a multicenter, randomized, double-blind study designed to compare the efficacy and safety of the investigational drug GNR-139 with the reference drug Eylea in treatment-naive patients with neovascular age-related macular degeneration (nAMD). Participants will be randomly assigned to receive either GNR-139 or Eylea. Neither the participants nor the study doctors will know which treatment is being administered. Both drugs will be given as an intravitreal injection dose of 8 mg (0.07 mL at a concentration of 114.3 mg/mL). Patients meeting the eligibility criteria will be randomised in a 2:1 ratio into one of two treatment groups: * Group I (GNR-139): 120 patients; * Group II (Eylea®): 60 patients. The main goal of the study is to evaluate if GNR-139 has similar efficacy to Eylea. This will be determined by measuring the change in the Best-Corrected Visual Acuity (BCVA) score at Week 8 in participants who completed the treatment.
1. Men and women aged ≥ 50 years at the time of signing the Informed Consent For...
1. Known hypersensitivity to aflibercept or to any of the excipients contained i...