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

Sponsor
Cinnagen
Study ID
NCT05587062
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 1, 2019
Status verified
Feb 2023
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022

Study Design

Enrollment
168 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept (CinnaGen Co, Iran)
    Aflibercept (CinnaGen Co, Iran) 2 mg (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
  • Active Comparator: Aflibercept (Regeneron, USA)
    Aflibercept (Regeneron, USA) 2 mg (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

Primary Outcome Measure

The proportion of patients achieving maintaining vision at week 52 [ Time Frame: At week 52 ]

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