Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)

NCT ID: NCT05155293

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2024-09-23

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.

Conditions

Neovascular (Wet) AMD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

AVT06 (proposed aflibercept biosimilar)

Intervention Type: DRUG

Patients will receive IVT injections of AVT06

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.

Group Type: EXPERIMENTAL

Eylea® (Aflibercept)

Intervention Type: DRUG

Patients will receive IVT injections of Eylea®

Interventions

AVT06 (proposed aflibercept biosimilar)

Patients will receive IVT injections of AVT06

Intervention Type: DRUG

Eylea® (Aflibercept)

Patients will receive IVT injections of Eylea®

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alvotech Swiss AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nemocnicni lekarna Sokolov

Sokolov, , Czechia

JSC Evex Medical Corporation

Tbilisi, , Georgia

Keneikai Hayashi Eye Hospital

Fukuoka, , Japan

Riga East University Hospital Clinical Centre "Bikernieki"

Riga, , Latvia

Pauls Stradins Clinical University Hospital SLLC

Riga, , Latvia

Fakultna Nemocnica Trencin

Trenčín, , Slovakia

Countries

Czechia; Georgia; Japan; Latvia; Slovakia

References

Agostini H, Baumane K, Balciuniene VJ, Ozols K, Soni R, Hamdi S, Cirillo S, Rai M, Otto H, Leutz S, Sattar A, Berti F. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opin Biol Ther. 2025 Jul;25(7):773-787. doi: 10.1080/14712598.2025.2519531. Epub 2025 Jun 17.

Reference Type: DERIVED

PMID: 40512025 (View on PubMed)

Other Identifiers

AVT06-GL-C01

Identifier Type: -

Identifier Source: org_study_id