Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03345901 · ClinicalTrials.gov registry record · Phase 3
PROMINENT-Eye Ancillary Study (Protocol AD)
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT03345901 is a Phase 3 study that was terminated before completion, run by Jaeb Center for Health Research. The registered enrollment target is 18 participants.
The verdict
NCT03345901, a Phase 3 study, was terminated before completion, sponsored by Jaeb Center for Health Research.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and visual loss from diabetic eye complications continues to be a leading cause of blindness in the US and other developed countries worldwide. Thus, even a modest ability to prevent DR onset or to slow DR worsening might substantially reduce the number of patients at risk for diabetes-related vision loss worldwide. Widespread use of an oral agent effective at reducing worsening of DR might also decrease the numbers of patients who undergo treatment for DR and diabetic macular edema (DME) and who are consequently at risk for side effects that adversely affect visual function. Two major studies of fenofibrate, the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD)-eye study, have demonstrated clinically important reduction in progression of retinopathy in patients with diabetes assigned to fibrate compared with placebo. However, despite the positive clinical trial results, fenofibrate has not gained wide acceptance as a preventive agent by either ophthalmologists or primary diabetes care providers. Thus, it is important to provide further evidence demonstrating whether or not selectively increasing peroxisome proliferator-activated receptor alpha (PPARα) activity reduces progression of retinopathy in patients with diabetes and non-proliferative diabetic retinopathy at baseline. Pemafibrate is a more potent and selective PPARα modulator than fenofibrate. Its efficacy is currently being evaluated in the Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) study for prevention of cardiovascular events in patients with type 2 diabetes. Given the large study cohort with a substantial proportion likely to have DR and the multi-year duration of th
Interventions
- DRUG Placebo
- DRUG Pemafibrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2019-04-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03345901
The ClinicalTrials.gov registry entry for NCT03345901 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03345901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03345901 about?
NCT03345901 is a clinical study titled "PROMINENT-Eye Ancillary Study (Protocol AD)". Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and visual loss from diabetic eye complications continues to be a leading cause of blindness in the US a...
What is the current status of trial NCT03345901?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2018-01-15. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT03345901?
The interventions under investigation include: Placebo (DRUG), Pemafibrate (DRUG).
Who is sponsoring clinical trial NCT03345901?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.