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NCT Number: NCT07489131

Clinical Study to Compare Efficacy and Safety of AVT29 and 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 3004

Budapest, Hungary

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVT29 (proposed aflibercept HD biosimilar)

Drug

Patients will receive IVT injections of AVT29

Eylea HD (aflibercept HD)

Drug

Patients will receive IVT injections of Eylea HD

Primary outcomes

  1. Change from baseline to Week 8 in BCVA as measured by ETDRS letter score

    Time frame: week 8

Study contacts

Contact information is provided by the study sponsor or research team.

Riken Soni

CONTACT

[email protected]

Silvia Cirillo

CONTACT

[email protected]

+41 78 659 89 89

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Registry information

Official study title

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

Acronym: ALVOEYE-HD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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