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

Primary Purpose

Neovascular (Wet) AMD

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AVT06 (proposed aflibercept biosimilar)

Eylea® (Aflibercept)

About this trial

This is an interventional treatment trial for Neovascular (Wet) AMD focused on measuring Macular Degeneration, Retinal Degeneration, Aflibercept

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Nemocnicni lekarna Sokolov
JSC Evex Medical Corporation
Keneikai Hayashi Eye Hospital
Riga East University Hospital Clinical Centre "Bikernieki"
Pauls Stradins Clinical University Hospital SLLC
Fakultna Nemocnica Trencin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AVT06 (proposed aflibercept biosimilar)

Eylea® (Aflibercept)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05155293

First Posted

December 1, 2021

Last Updated

September 25, 2023

Sponsor

Alvotech Swiss AG

1. Study Identification

Unique Protocol Identification Number

NCT05155293

Brief Title

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

Acronym

ALVOEYE

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 28, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alvotech Swiss AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular (Wet) AMD

Keywords

Macular Degeneration, Retinal Degeneration, Aflibercept

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

413 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AVT06 (proposed aflibercept biosimilar)

Arm Type

Experimental

Arm 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.

Arm Title

Eylea® (Aflibercept)

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

AVT06 (proposed aflibercept biosimilar)

Intervention Description

Patients will receive IVT injections of AVT06

Intervention Type

Drug

Intervention Name(s)

Eylea® (Aflibercept)

Intervention Description

Patients will receive IVT injections of Eylea®

Primary Outcome Measure Information:

Title

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

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans-Juergen Agostini

Organizational Affiliation

University Clinic Freiburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nemocnicni lekarna Sokolov

City

Sokolov

ZIP/Postal Code

35601

Country

Czechia

Facility Name

JSC Evex Medical Corporation

City

Tbilisi

Country

Georgia

Facility Name

Keneikai Hayashi Eye Hospital

City

Fukuoka

ZIP/Postal Code

812 0011

Country

Japan

Facility Name

Riga East University Hospital Clinical Centre "Bikernieki"

City

Riga

ZIP/Postal Code

10006

Country

Latvia

Facility Name

Pauls Stradins Clinical University Hospital SLLC

City

Riga

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Fakultna Nemocnica Trencin

City

Trenčín

ZIP/Postal Code

911 71

Country

Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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