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NCT04411693 · ClinicalTrials.gov registry record · Phase 4
Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT04411693 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 23 participants.
The verdict
NCT04411693, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period. Subjects will be evaluated every month for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol. In addition, ultra-widefield angiography will be performed at run-in visit, baseline, month 3, and month 6.
Interventions
- DRUG Aflibercept
- DRUG Dexamethasone implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-04-10 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04411693
The ClinicalTrials.gov registry entry for NCT04411693 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aflibercept is the first listed.
NCT04411693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04411693 about?
NCT04411693 is a clinical study titled "Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema". This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months followin...
What is the current status of trial NCT04411693?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2020-04-10. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT04411693?
The interventions under investigation include: Aflibercept (DRUG), Dexamethasone implant (DRUG).
Who is sponsoring clinical trial NCT04411693?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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