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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05155293

Acronym

ALVOEYE

Enrollment

413

Registered

2021-12-13

Start date

2022-06-28

Completion date

2024-09-23

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular (Wet) AMD

Keywords

Macular Degeneration, Retinal Degeneration, Aflibercept

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.

Interventions

DRUGAVT06 (proposed aflibercept biosimilar)

Patients will receive IVT injections of AVT06

DRUGEylea® (Aflibercept)

Patients will receive IVT injections of Eylea®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)	Week 8

Countries

Czechia, Georgia, Japan, Latvia, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026