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

September 26, 2024 updated by: Alvotech Swiss AG

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

413

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Sokolov, Czechia, 35601
        • Nemocnicni lekarna Sokolov
  • Georgia
      • Tbilisi, Georgia
        • JSC Evex Medical Corporation
  • Japan
      • Fukuoka, Japan, 812 0011
        • Keneikai Hayashi Eye Hospital
  • Latvia
      • Riga, Latvia, 10006
        • Riga East University Hospital Clinical Centre "Bikernieki"
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital SLLC
  • Slovakia
      • Trenčín, Slovakia, 911 71
        • Fakultna nemocnica Trencin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVT06 (proposed aflibercept biosimilar)
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)
Patients will receive IVT injections of AVT06
Experimental: Eylea® (Aflibercept)
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)
Patients will receive IVT injections of Eylea®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvotech Swiss AG

Investigators

  • Principal Investigator: Hans-Juergen Agostini, University clinic Freiburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Actual)

November 17, 2023

Study Completion (Actual)

September 23, 2024

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVT06-GL-C01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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