NCT05155293CompletedPhase 3
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)
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 413 (actual)
- First submitted
- 1 Dec 2021
- Start date
- 28 Jun 2022
- Primary completion date
- 17 Nov 2023
- Lead sponsor
- Alvotech Swiss AG
- Diseases
- Macular degeneration
- NCT number
- NCT05155293
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 413
- From 28 Jun 2022 to the primary completion date, 17 Nov 2023
- 6 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior systemic treatment with anti-VEGF therapy
- 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
Other illness
- 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
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemocnicni lekarna Sokolov Coordinator of this site? Confirm its status | Sokolov | Czechia | Unknown status |
| JSC Evex Medical Corporation Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Keneikai Hayashi Eye Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Riga East University hospital, clinical centre Bikernieki Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Pauls Stradins Clinical University Hospital SLLC Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Fakultna nemocnica Trencin Coordinator of this site? Confirm its status | Trenčín | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.