Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
324

Summary

Conditions
Diabetic Macular Edema
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the studyMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Masked study drug kits will be supplied to sites as necessary during the study. The outside label of the box will not reveal the identity of the product inside (whether it is Eylea or MYL-1701P) and will be assigned in a masked fashion through the IRT system. An un-masked team will identified at site, to be responsible for preparation and administration of the study drug.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 a...

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.

Tracking Information

NCT #
NCT03610646
Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
Not Provided
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