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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: Completed Phase 4 study, sponsored by The Cleveland Clinic.
NCT04411693 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
It is defined as the mean change in the thickness between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) in the central 1mm. Discrepancy in total number relates to variable follow up for evaluation of change in parameter.
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 |
What the finished NCT04411693 record still lists
NCT04411693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Aflibercept is the first listed.
NCT04411693 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04411693's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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