Trials / Completed
CompletedNCT04522167
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 434 (actual)
- Sponsor
- Bioeq GmbH · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FYB203 (Proposed aflibercept biosimilar) | Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
| DRUG | Eylea® (Aflibercept) | Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
Timeline
- Start date
- 2020-07-21
- Primary completion
- 2022-06-23
- Completion
- 2023-05-18
- First posted
- 2020-08-21
- Last updated
- 2025-11-13
- Results posted
- 2025-11-13
Locations
66 sites across 9 countries: Bulgaria, Czechia, Hungary, Israel, Italy, Japan, Poland, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04522167. Inclusion in this directory is not an endorsement.