Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema (ALVOEYE-HD)

April 27, 2026 updated by: Alvotech Swiss AG

A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema

This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

256

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 Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Site 3004

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Participant is ≥18 years old at the time of signing the ICF.
  • Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.
  • Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.
  • Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20/40 to 20/200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.
  • Participant's decrease in vision is determined to be primarily the result of DME in the study eye.

Main Exclusion Criteria:

  • previous treatment with anti-VEGF therapy
  • history or concurrent disease other than DME that could compromise visual acuity
  • 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
  • participants 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVT29 (proposed aflibercept HD biosimilar)
Participants will receive 1 IVT injection of AVT29 at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.
Drug: AVT29 (proposed aflibercept HD biosimilar)
Patients will receive IVT injections of AVT29
Active Comparator: Eylea HD (aflibercept HD)
Participants will receive 1 IVT injection of Eylea HD at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.
Drug: Eylea HD (aflibercept HD)
Patients will receive IVT injections of Eylea HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
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

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)

April 22, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AVT29-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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