Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) (ALVOEYE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05155293|
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : April 27, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Neovascular (Wet) AMD||Drug: AVT06 (proposed aflibercept biosimilar) Drug: Eylea® (Aflibercept)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||444 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Actual Study Start Date :||June 28, 2022|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
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.
Drug: AVT06 (proposed aflibercept biosimilar)
Patients will receive IVT injections of AVT06
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.
Drug: Eylea® (Aflibercept)
Patients will receive IVT injections of Eylea®
- Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA) [ Time Frame: Week 8 ]
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155293
|Contact: Stephanie Koelblemail@example.com|
|Contact: Riken Sonifirstname.lastname@example.org|
|Nemocnicni lekarna Sokolov||Recruiting|
|Sokolov, Czechia, 35601|
|Contact: Andrej Farkas|
|JSC Evex Medical Corporation||Recruiting|
|Contact: Mikheil Omiadze|
|Keneikai Hayashi Eye Hospital||Recruiting|
|Fukuoka, Japan, 812 0011|
|Contact: Ken Hayashi|
|Riga East University Hospital Clinical Centre "Bikernieki"||Recruiting|
|Riga, Latvia, 10006|
|Contact: Kristine Baumane|
|Pauls Stradins Clinical University Hospital SLLC||Recruiting|
|Riga, Latvia, 1002|
|Contact: Guna Laganovska|
|Fakultna Nemocnica Trencin||Recruiting|
|Trenčín, Slovakia, 911 71|
|Contact: Marek Kacerik|
|Principal Investigator:||Hans-Juergen Agostini||University Clinic Freiburg|
|Responsible Party:||Alvotech Swiss AG|
|Other Study ID Numbers:||
|First Posted:||December 13, 2021 Key Record Dates|
|Last Update Posted:||April 27, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Angiogenesis Modulating Agents
Physiological Effects of Drugs