Fenofibrate for Prevention of DR Worsening
Public ClinicalTrials.gov record NCT04661358. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.
Study identification
- NCT ID
- NCT04661358
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 563 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 5, 2021 (Actual)
- Primary completion
- Dec 2029 (Estimated)
- Completion
- Dec 2029 (Estimated)
- Last update posted
- Jun 29, 2026
2021 – 2029
United States locations
- U.S. sites
- 66
- U.S. states
- 23
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kent W. Small, MD, AMC | Glendale | California | 91203-1971 | — |
| Salehi Retina Institute Inc. | Huntington Beach | California | 92647-8693 | — |
| Loma Linda University | Loma Linda | California | 92354 | — |
| UCLA Stein Eye Institute | Pasadena | California | 91103 | — |
| Regents of the University of California, Davis, DBA University of California, Davis | Sacramento | California | 95817 | — |
| The Regents of the University of California, San Francisco | San Francisco | California | 94110 | — |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | — |
| University of Florida- Jacksonville | Jacksonville | Florida | 32209 | — |
| Florida Retina Institute, James A. Staman, MD, PA- Jacksonville | Jacksonville | Florida | 32216 | — |
| Florida Retina Consultants | Lakeland | Florida | 33805 | — |
| Florida Retina Institute, James A. Staman, MD, PA- Orlando | Orlando | Florida | 32806-1101 | — |
| Southeast Eye Institute, P.A. dba Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | — |
| Retina Vitreous Consultants, LLP | Sarasota | Florida | 34233-1261 | — |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | — |
| SEASHORE RETINA LLC DBA Retina Specialists of Tampa | Wesley Chapel | Florida | 33544 | — |
| Southeast Retina Center, P.C. | Augusta | Georgia | 30909 | — |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | — |
| Thomas Eye Group | Sandy Springs | Georgia | 30328 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| UIC - Dept of Ophthalmology & Visual Sciences | Chicago | Illinois | 60612 | — |
| Illinois Retina Associates SC - Oak Park Site | Oak Park | Illinois | 60304 | — |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | — |
| John Kenyon American Eye Institute, LLC | New Albany | Indiana | 47150 | — |
| Wolfe Eye Clinic-Cedar Rapids | Hiawatha | Iowa | 52233 | — |
| Wolfe Clinic, P.C.- West Des Moines | West Des Moines | Iowa | 50266-7705 | — |
| Mid-America Retina Consultants, P.A. | Overland Park | Kansas | 66211 | — |
| University of Kansas Medical Center Research Institute, Inc. | Prairie Village | Kansas | 66208 | — |
| Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana | West Monroe | Louisiana | 71291-4452 | — |
| Elman Retina Group, P.A. | Baltimore | Maryland | 21237 | — |
| Valley Eye Physicians and Surgeons | Ayer | Massachusetts | 01432 | — |
| Boston Medical Center Corporation | Boston | Massachusetts | 02118 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202-2689 | — |
| Foundation for Vision Research and Retina Specialists of Michigan, P.C. | Grand Rapids | Michigan | 49546 | — |
| Vitreo-Retinal Associates | Grand Rapids | Michigan | 49546 | — |
| Retina Center, PA DBA Retina Center of Minnesota | Minneapolis | Minnesota | 55404 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| The Curators of the University of Missouri | Columbia | Missouri | 65201-5276 | — |
| Washington University Ophthalmology | St Louis | Missouri | 63110 | — |
| Retina Research Institute, LLC | St Louis | Missouri | 63128-1729 | — |
| Retina-Vitreous Surgeons of Central NY, PC | Liverpool | New York | 13088 | — |
| MaculaCare | New York | New York | 10021 | — |
| Retina Associates of Western NY, P.C. | Rochester | New York | 14620-4655 | — |
| Pamela Weber, MD/Island Retina | Shirley | New York | 11967 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | — |
| The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine | Cleveland | Ohio | 44120 | — |
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | — |
| Verum Research LLC | Eugene | Oregon | 97401 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Retina Consultants, LLC | Salem | Oregon | 97302 | — |
| Cascade Medical Research Institute, LLC | Springfield | Oregon | 97477 | — |
| Retina-Vitreous Consultants, Inc. | Monroeville | Pennsylvania | 15146 | — |
| Pittsburg Clinical Trial Consortium | Sewickley | Pennsylvania | 15143 | — |
| Southeastern Retina Associates, P.C. | Knoxville | Tennessee | 37922 | — |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | — |
| Austin Research Center for Retina | Austin | Texas | 78705 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Retina Consultants of Texas | Beaumont | Texas | 77707 | — |
| Retina Consultants of Texas, PA | Bellaire | Texas | 77401 | — |
| Baylor College of Medicine, Baylor Eye Physicians and Surgeons | Houston | Texas | 77030-4101 | — |
| Texas Retina Associates | Lubbock | Texas | 79424 | — |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | — |
| University of Washington | Seattle | Washington | 98104 | — |
| Gunderson Health System | La Crosse | Wisconsin | 54601 | — |
| Eye Clinic of Wisconsin | Wausau | Wisconsin | 54403 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04661358, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04661358 live on ClinicalTrials.gov.