Trials / Completed
CompletedNCT05155293
Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 413 (actual)
- Sponsor
- Alvotech Swiss AG · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AVT06 (proposed aflibercept biosimilar) | Patients will receive IVT injections of AVT06 |
| DRUG | Eylea® (Aflibercept) | Patients will receive IVT injections of Eylea® |
Timeline
- Start date
- 2022-06-28
- Primary completion
- 2023-11-17
- Completion
- 2024-09-23
- First posted
- 2021-12-13
- Last updated
- 2024-09-27
Locations
6 sites across 5 countries: Czechia, Georgia, Japan, Latvia, Slovakia
Source: ClinicalTrials.gov record NCT05155293. Inclusion in this directory is not an endorsement.