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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlvotech Swiss AG

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AVT29 (proposed aflibercept HD biosimilar)
  • Eylea HD (aflibercept HD)

Treatment groups

256 Participants
are divided into 2 treatment groups

Sponsors and collaborators