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

Alvotech

Status and phase: Completed; Phase 3

Conditions: Neovascular (Wet) AMD

Treatments: Drug: Eylea® (Aflibercept); Drug: AVT06 (proposed aflibercept biosimilar)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05155293

AVT06-GL-C01

Details and patient eligibility

About

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.

Enrollment: 413 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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413 participants in 2 patient groups

AVT06 (proposed aflibercept biosimilar)

Experimental group

Description:

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.

Treatment:

Drug: AVT06 (proposed aflibercept biosimilar)

Eylea® (Aflibercept)

Experimental group

Description:

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.

Treatment:

Drug: Eylea® (Aflibercept)