A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening

What this Trial Is About

Researchers are evaluating fenofibrate compared with a placebo to prevent worsening of diabetic retinopathy DR over six years in adults with mild to moderately severe non-proliferative DR and no center-involved diabetic macular edema at the start. The study also explores how eye doctors might work with primary care providers to safely prescribe and monitor fenofibrate. Additionally, the study will assess how blood sugar fluctuations relate to DR outcomes and include extra research on functional and structural eye changes in participants. Participants receive either fenofibrate or a placebo, with doses of 160 mg or 54 mg daily depending on kidney function, taken with food. The dose may be adjusted during follow-up visits following study guidelines. Treatment and monitoring continue through six years, allowing researchers to compare the effects of fenofibrate against placebo on DR progression. During the study, participants undergo regular eye exams, including grading of fundus photographs and visual acuity tests to monitor retinopathy status. Researchers will track DR worsening as the primary outcome and observe other outcomes such as eye procedures for DR or diabetic macular edema, development of diabetic macular edema affecting vision, and any vision loss. Safety is monitored through kidney function tests and other clinical assessments throughout the six-year follow-up period.

Fenofibrate for Prevention of DR Worsening