Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema
Status:
Completed
Trial end date:
2021-09-10
Target enrollment:
Participant gender:
Summary
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with
central DME involvement will be randomized 1:1 to intravitreal treatment with MYL-1701P or
Eylea®.
The primary endpoint will be mean change from baseline in BCVA as assessed by ETDRS letters.
Pharmacokinetics (PK) and immunogenicity will be evaluated in the subjects participating in
the study.