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
participants 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.
Phase:
Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborators:
Juvenile Diabetes Research Foundation National Eye Institute (NEI) National Institutes of Health (NIH) Roche Pharma AG The Leona M. and Harry B. Helmsley Charitable Trust