Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
- Sponsor
- Alvotech Swiss AG
- Study ID
- NCT05155293
- Phase
- PHASE3
- Status
- Completed
Conditions
- Neovascular (Wet) AMD
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AVT06 (proposed aflibercept biosimilar) — DRUGPatients will receive IVT injections of AVT06
- Eylea® (Aflibercept) — DRUGPatients will receive IVT injections of Eylea®
Study Details
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.
Key Dates
- Start date
- Jun 28, 2022
- Status verified
- Sep 2024
- Primary completion
- Nov 17, 2023
- Completion
- Sep 23, 2024
Study Design
- Enrollment
- 413 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: AVT06 (proposed aflibercept biosimilar)Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
- Experimental: Eylea® (Aflibercept)Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Primary Outcome Measure
Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA) [ Time Frame: Week 8 ]