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Completed

NCT Number: NCT05155293

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

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.

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Key information

Conditions

Neovascular (Wet) AMD Eye Diseases Eye Diseases, Hereditary Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nemocnicni lekarna Sokolov, Sokolov, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVT06 (proposed aflibercept biosimilar)

Drug

Patients will receive IVT injections of AVT06

Eylea® (Aflibercept)

Drug

Patients will receive IVT injections of Eylea®

Primary outcomes

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

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Registry information

Official study 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)

Acronym: ALVOEYE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 13, 2021
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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