RecruitingPhase 3NCT07489131

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

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

Sponsor

Alvotech Swiss AG

Enrollment

256 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetic Macular Edema

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria4

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.

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