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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05155293
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Alvotech Swiss AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neovascular (Wet) AMD Drug: AVT06 (proposed aflibercept biosimilar) Drug: Eylea® (Aflibercept) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : June 28, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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®


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA) [ Time Frame: Week 8 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155293


Contacts
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Contact: Stephanie Koelbl +4915128088914 stephanie.koelbl@alvotech.com
Contact: Riken Soni riken.soni@alvotech.com

Locations
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Czechia
Nemocnicni lekarna Sokolov Recruiting
Sokolov, Czechia, 35601
Contact: Andrej Farkas         
Georgia
JSC Evex Medical Corporation Recruiting
Tbilisi, Georgia
Contact: Mikheil Omiadze         
Japan
Keneikai Hayashi Eye Hospital Recruiting
Fukuoka, Japan, 812 0011
Contact: Ken Hayashi         
Latvia
Riga East University Hospital Clinical Centre "Bikernieki" Recruiting
Riga, Latvia, 10006
Contact: Kristine Baumane         
Pauls Stradins Clinical University Hospital SLLC Recruiting
Riga, Latvia, 1002
Contact: Guna Laganovska         
Slovakia
Fakultna Nemocnica Trencin Recruiting
Trenčín, Slovakia, 911 71
Contact: Marek Kacerik         
Sponsors and Collaborators
Alvotech Swiss AG
Investigators
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Principal Investigator: Hans-Juergen Agostini University Clinic Freiburg
More Information
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Responsible Party: Alvotech Swiss AG
ClinicalTrials.gov Identifier: NCT05155293    
Other Study ID Numbers: AVT06-GL-C01
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alvotech Swiss AG:
Macular Degeneration
Retinal Degeneration
Aflibercept
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents