Protocol Number: AF
Primary Investigator: Thomas Aaberg, Jr., M.D.
The purpose of this study is to determine whether fenofibrate can slow or prevent worsening diabetic retinopathy. Over time, diabetic retinopathy can get worse and cause changes in the retina that lead to poor vision. Usually, diabetic retinopathy is watched closely by an eye doctor but not treated with laser or injection until it gets worse and might affect the patient's vision.
Results from past studies have suggested that fenofibrate prevents the worsening of diabetic retinopathy. However, both studies were primarily testing fenofibrate for the prevention of heart disease and/or stroke in people with type 2 diabetes. Studying the effect on diabetic retinopathy was not the main reason for doing the study, and the benefit was only seen in a small group of people who already had diabetic retinopathy. Therefore, we are doing this study specifically in patients with diabetic retinopathy to confirm whether fenofibrate is beneficial for preventing worsening.
We also want to find out more information about how daily blood sugar values affect diabetic retinopathy. With new monitoring devices that measure sugar levels continuously, we can find out how specific changes during the day might affect eye disease. Therefore, participants in this study will be asked to wear a Continuous Glucose Monitor (CGM) for about 10 days every 6 months.
In addition, this study will also be used to collect information on how certain tests of visual function change over time in people with diabetic retinopathy. For example, in a prior study of eyes with more advanced disease, peripheral field vision, or the ability to see objects on the side, got worse over time. We want to learn more about these different aspects of vision and how they are affected by changes in diabetic retinopathy. These additional tests will only be performed if available at your doctor’s office.
Please click here for more detailed clinical information on the study.