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.
Diabetic Retinopathy
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.
Fenofibrate for Prevention of DR Worsening
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Kent W. Small, MD, AMC, Glendale, California, United States, 91203-1971
Salehi Retina Institute Inc., Huntington Beach, California, United States, 92647-8693
Loma Linda University, Loma Linda, California, United States, 92354
Regents of the University of California, Davis, DBA University of California, Davis, Sacramento, California, United States, 95817
The Regents of the University of California, San Francisco, San Francisco, California, United States, 94110
National Ophthalmic Research Institute, Fort Myers, Florida, United States, 33912
University of Florida- Jacksonville, Jacksonville, Florida, United States, 32209
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville, Jacksonville, Florida, United States, 32216
Florida Retina Consultants, Lakeland, Florida, United States, 33805
Florida Retina Institute, James A. Staman, MD, PA- Orlando, Orlando, Florida, United States, 32806-1101
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 80 Years
ALL
No
Jaeb Center for Health Research,
Emily Y Chew, MD, STUDY_CHAIR, National Institutes of Health (NIH)
2029-04