Hiawatha

Researchers are evaluating the effect of fenofibrate compared with placebo in preventing worsening of diabetic retinopathy (DR) over six years in people with mild to moderately severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) at the start. The study also aims to test a model where ophthalmologists collaborate with primary care providers like internists or endocrinologists to safely prescribe and monitor the drug. Additionally, the study will assess how blood sugar variability relates to DR outcomes and will include additional studies to understand functional and structural eye changes in participants. Participants will receive either fenofibrate or placebo daily with food, with the dose (either 160mg or 54mg) chosen based on kidney function measured at screening. The dose may be adjusted during follow-up according to the study protocol. The trial is randomized and includes a comparison between the fenofibrate and placebo groups. During the study, participants will be monitored for worsening of diabetic retinopathy over six years. Eye health will be assessed through specialized grading of fundus photographs and visual acuity tests. Kidney function and blood sugar variability will also be tracked. The main outcome measured is the progression of diabetic retinopathy. Researchers will observe safety and effectiveness while participants remain in the study for the full six-year period.