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.
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.
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.
Parallel
AVT29 (proposed aflibercept HD biosimilar)
DrugPatients will receive IVT injections of AVT29
Eylea HD (aflibercept HD)
DrugPatients will receive IVT injections of Eylea HD
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
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