Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic⦠(NCT07489131) | Clinical Trial Compass
RecruitingPhase 3
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
Hungary256 participantsStarted 2026-04-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
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Main Inclusion Criteria:
* Participant is ā„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 Ģs 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.
What they're measuring
1
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score