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NCT03610646 · ClinicalTrials.gov registry record · Phase 3
Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
A Phase 3 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 355
- Enrollment target
NCT03610646: Completed Phase 3 study, sponsored by Mylan Pharmaceuticals.
NCT03610646 is a Phase 3 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 355 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03610646, a Phase 3 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 355 participants
- Enrollment target
Study 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.
Primary Outcome
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improve
Interventions
- DRUG Eylea
- DRUG MYL-1701P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2018-08-23 |
| Est. Completion | 2021-09-10 |
| Phase | Phase 3 |
What the finished NCT03610646 record still lists
NCT03610646 is an interventional study that assigns participants to a tested intervention. The registered 355 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Eylea is the first listed.
NCT03610646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03610646 about?
NCT03610646 is a clinical study titled "Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)". 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 Trea...
What is the current status of trial NCT03610646?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 355 participants. The study started on 2018-08-23. Estimated completion is 2021-09-10.
What interventions are being tested in trial NCT03610646?
The interventions under investigation include: Eylea (DRUG), MYL-1701P (DRUG).
Who is sponsoring clinical trial NCT03610646?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03610646's enrollment target sits among peer trials
355 1025th of 2000 higher than 975 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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