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A Study to Compare GNR-139 and Eylea® in Patients With nAMD

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 14 of 14 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AO GENERIUM
9 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07844148
Lead Sponsor AO GENERIUM
Conditions
(from sponsor)		 nAMD
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov