CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 355 enrolled
Drug / intervention
MYL-1701P +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03610646
NCT03610646Phase 3Completed
CompareCT.gov

A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

Mylan Pharmaceuticals Inc·interventional·Posted Aug 1, 2018·Updated Mar 7, 2023

In Brief

A Phase 3 clinical trial evaluating MYL-1701P and Eylea for Diabetic Macular Edema. Completed, enrolled 355 participants across 73 sites in 9 countries.

Detailed Summary

Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesCzechia, Germany, Hungary, India, Japan, Latvia, Poland, Russia, United States
CollaboratorsMomenta Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 1, 2018
Enrollment StartAug 23, 2018
Primary CompletionNov 10, 2020
Study CompletionSep 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.9 years ago

Interventions

MYL-1701Pdrug

Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.

Eyleadrug

Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.