Age-Related Macular Degeneration Clinical Trial
Official title:
A Phase III, Multicenter, Randomized, Two-armed, Double-blind, Parallel, Active-controlled, Non-inferiority Clinical Trial to Compare Efficacy and Safety of Aflibercept (CinnaGen Co, Iran) to the Reference Aflibercept Product (Eylea®, Regeneron, USA) in Patients With Neovascular Age-related Macular Degeneration.
The purpose of this study is to evaluate the efficacy and safety of Aflibercept (produced by CinnaGen Co, Iran) compared with Eylea® (Regeneron, USA) in subjects with Neovascular Age-related Macular Degeneration (nAMD). All the participants will receive one of the following regimens: Aflibercept (CinnaGen Co, Iran) or Eylea® (Regeneron, USA), 2 mg (vial 0.05 ml) by intravitreal injection every 4 weeks for the first 3 injections, followed by 2 mg every 8 weeks until week 48 of study. The primary objective of this study is to verify the non-inferiority of Aflibercept (CinnaGen Co, Iran) versus Eylea® (Regeneron, USA) in achieving maintaining vision (losing<15 letter on ETDRS chart) at week 52 in comparison to week 0 in participants with Neovascular AMD.
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