Fenofibrate for Prevention of DR Worsening (Protocol AF)
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|ClinicalTrials.gov Identifier: NCT04661358|
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : February 10, 2023
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This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 4 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: Fenofibrate Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||910 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-masked, placebo-controlled clinical trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening|
|Actual Study Start Date :||March 5, 2021|
|Estimated Primary Completion Date :||April 2027|
|Estimated Study Completion Date :||April 2027|
|Experimental: Fenofibrate 160-mg||
Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
|Placebo Comparator: Placebo||
Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
- Worsening of diabetic retinopathy [ Time Frame: 4- years ]
- 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs.
- Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography.
- Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.
- Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy [ Time Frame: 4 years ]
- Development of CI-DME [ Time Frame: 4 years ]Defined as, either 1) at least a 10% increase in OCT central subfield thickness from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), and Investigator determination that thickening cannot be attributed to any cause other than CI-DME, or 2)Intraocular DME treatment including focal/grid laser, intraocular anti-VEGF, intraocular corticosteroid, or vitrectomy
- Development of center-involved diabetic macular edema with vision loss [ Time Frame: 4 years ]Defined as either 1) an increase in OCT central subfield thickness of 10% or more from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), investigator determination that thickening cannot be attributed to any cause other than DME, and a decrease in visual acuity from baseline of 10 or more letters at a single visit or 5 to 9 letters at 2 consecutive visits at least 21 days apart with vision loss presumed to be from DME, intraocular DME or 2) treatment including focal/grid laser, anti-VEGF, corticosteroid injection, or vitrectomy
- Visual acuity loss from any cause [ Time Frame: 4 years ]Defined as a decrease in visual acuity from baseline of 10 or more letters at a single visit or a 5 to 9-letter decrease at 2 consecutive visits at least 21 days apart regardless of whether vision loss is presumed to be from DME or any other cause
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria
- Age ≥18 years and < 80 years.
- Type 1 or type 2 diabetes.
At least one eye with the following:
- Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.
- Best-corrected E-ETDRS visual acuity letter score of ≥79 (approximate Snellen equivalent 20/25 or better).
- If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)
Key Exclusion Criteria
Eye-level exclusion criteria (the eye is ineligible if any of the following is met):
Current CI-DME based on clinical exam or OCT central subfield thickness (CST)
- Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men
- Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men
- Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior.
- History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication
Participant-level exclusion criterion (the participant is ineligible if the following criterion is met):
• Decreased renal function, defined as requiring dialysis or central laboratory eGFR value < 45 mL/min/1.73 m2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661358
|Contact: Adam R Glassman, MSemail@example.com|
|Contact: Emily Chew, MD|
|Study Chair:||Emily Y Chew, MD||National Institutes of Health (NIH)|
|Responsible Party:||Jaeb Center for Health Research|
|Other Study ID Numbers:||
DRCR.net Protocol AF
U10EY014231 ( U.S. NIH Grant/Contract )
|First Posted:||December 10, 2020 Key Record Dates|
|Last Update Posted:||February 10, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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