Effects of Fenofibric Acid on Diabetic Macular Edema: The MacuFen study

Abstract

Purpose: Fenofibrate reduced progression of diabetic retinopathy in two large randomized studies. The effect of 135 mg fenofibric acid on diabetic macular edema (DME) was evaluated in subjects with existing DME.Methods: In this double-blind, randomized, placebo-controlled study, 110 subjects with DME not requiring immediate photocoagulation or intraocular treatment with adequate diabetes and blood pressure control received either fenofibric acid or placebo once daily for 1 year. Total macula volume (TMV) and thickness were measured in the worse eye and all eligible eyes with time-domain optical coherence tomography at baseline and quarterly thereafter.Results: TMV decreased by −0.35 mm3 (within-group difference) after fenofibric acid treatment and by −0.11 mm3 after placebo. The between-group comparison of the change was −0.25 mm3 (95% confidence interval, CI, −0.645–0.155; p = 0.227, worse eye analysis). Weighted inner zone thickness and volume decreased by −18.7 µm and −0.13 mm3, respectively, for within group difference after fenofibric acid and by −3.1 µm and −0.02 mm3, respectively, after placebo. Considering all eligible eyes, thicknesses at central zone, mean inner zone, and entire retina decreased by −21.3 µm, −19.8 µm, and −20.4 µm, respectively, after fenofibric acid. No between-group difference in changes of these measurements was observed. Triglycerides decreased by 23% after fenofibric acid (vs 4% after placebo, p = 0.001) and high-density lipoprotein cholesterol increased by 8% (vs 0.3%, p = 0.014). No safety concern was identified.Conclusion: Subjects treated with fenofibric acid had a modest improvement in TMV, although the study was probably underpowered to detect a benefit over placebo after 1 year.