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

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.