For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Subject must be ≥50 years of age, at the time of signing the informed consent.
  2. Subjects must be diagnosed with neovascular (wet) AMD in the study eye.
  3. Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD.
  4. Willingness and ability to undertake all scheduled visits and assessments.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Any prior systemic treatment with anti-VEGF therapy
  2. 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
  3. 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
  4. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Neovascular (Wet) AMD

Age (in years)

50+

Phase

Phase 3

Participants needed

413

Est. Completion Date

Jan 31, 2025

Treatment type

Interventional


Sponsor

Alvotech Swiss AG

ClinicalTrials.gov identifier

NCT05155293

Study number

AVT06-GL-C01

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