Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
Phase 3
Active, not recruiting
- Conditions
- Neovascular (Wet) AMD
- Interventions
- Drug: AVT06 (proposed aflibercept biosimilar)
- Registration Number
- NCT05155293
- Lead Sponsor
- Alvotech Swiss AG
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 413
Inclusion Criteria
- Subject must be ≥50 years of age, at the time of signing the informed consent.
- Subjects must be diagnosed with neovascular (wet) AMD in the study eye.
- Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD.
- Willingness and ability to undertake all scheduled visits and assessments.
Exclusion Criteria
- Any prior systemic treatment with anti-VEGF therapy
- Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
- Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment
- Subjects not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eylea® (Aflibercept) 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. AVT06 (proposed aflibercept biosimilar) 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.
- Primary Outcome Measures
Name Time Method Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA) Week 8
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Nemocnicni lekarna Sokolov
🇨🇿Sokolov, Czechia
JSC Evex Medical Corporation
🇬🇪Tbilisi, Georgia
Pauls Stradins Clinical University Hospital SLLC
🇱🇻Riga, Latvia
Riga East University Hospital Clinical Centre "Bikernieki"
🇱🇻Riga, Latvia
Keneikai Hayashi Eye Hospital
🇯🇵Fukuoka, Japan
Fakultna Nemocnica Trencin
🇸🇰Trenčín, Slovakia