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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 is a Phase 3 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 355 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03610646
The ClinicalTrials.gov registry entry for NCT03610646 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 355 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Eylea is the first listed.
NCT03610646 reports 0 study locations.
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.
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