Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Summary

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.

Timeline

Start

2019-10-01

Primary completion

2022-07-31

Completion

2022-07-31

Drugs

Indications