Austin Retina Associates | Main | Austin, TX
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About
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.
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Inclusion and exclusion criteria
Key Inclusion Criteria
Age ≥18 years and < 80 years.
Type 1 or type 2 diabetes.
At least one eye with the following:
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)
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
Primary purpose
Allocation
Interventional model
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560 participants in 2 patient groups, including a placebo group
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Central trial contact
Adam R Glassman, MS; Emily Chew, MD
Data sourced from clinicaltrials.gov
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