Trials / Completed
CompletedNCT05587062
Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Cinnagen · Industry
- Sex
- All
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Aflibercept (CinnaGen Co, Iran) | Aflibercept (CinnaGen Co, Iran) by intravitreal injection |
| BIOLOGICAL | Aflibercept (Regeneron, USA) | Aflibercept (Regeneron, USA) by intravitreal injection |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
- First posted
- 2022-10-19
- Last updated
- 2023-02-14
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT05587062. Inclusion in this directory is not an endorsement.