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

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.

Main Inclusion Criteria:

• 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.

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 ́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.