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

RecruitingPhase 3Ages 18 Years - anyAllAlvotech Swiss AG
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Main Inclusion Criteria: * Participant is โ‰ฅ18 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 ฬ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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What it tests

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

1 site
Site 3004
Budapest, Hungary
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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