Last updated on December 2019

Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea in Subjects With Diabetic Macular Edema


Brief description of study

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.

Detailed Study Description

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. Subjects will receive the assigned treatment until Week 48.

All subjects will return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. There will be additional visits during the study as specified in the study schedule for safety and pharmacokinetic evaluation.

Pharmacokinetics (PK) and Immunogenicity will be assessed in the subjects participating in the study.

Clinical Study Identifier: NCT03610646

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Recruitment Status: Open


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