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

NCT05155293 | Completed Phase 3 DMC

• 1 other identifier: AVT06-GL-C01
• Study Type: interventional
• Target: 413
• Locations: 5 countries
• Sites: 6

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

Keywords

Macular Degeneration; Retinal Degeneration; Aflibercept

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)

  Week 8

Study Arms (2)

AVT06 (proposed aflibercept biosimilar)

EXPERIMENTAL

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)

Eylea® (Aflibercept)

EXPERIMENTAL

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)

Interventions

AVT06 (proposed aflibercept biosimilar) DRUG

Patients will receive IVT injections of AVT06

AVT06 (proposed aflibercept biosimilar)

Eylea® (Aflibercept) DRUG

Patients will receive IVT injections of Eylea®

Eylea® (Aflibercept)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (6)

Nemocnicni lekarna Sokolov

Sokolov, 35601, Czechia

Location

JSC Evex Medical Corporation

Tbilisi, Georgia

Location

Keneikai Hayashi Eye Hospital

Fukuoka, 812 0011, Japan

Location

Riga East University Hospital Clinical Centre "Bikernieki"

Riga, 10006, Latvia

Location

Pauls Stradins Clinical University Hospital SLLC

Riga, 1002, Latvia

Location

Fakultna Nemocnica Trencin

Trenčín, 911 71, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 40512025 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Retinal Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 13, 2021
• Study Start: June 28, 2022
• Primary Completion: November 17, 2023
• Study Completion: September 23, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CZ (1); LA (2); SL (1); GE (1); JP (1)