Effects of fenofibric acid on diabetic macular edema: the MacuFen study

Pascale Massin, Tunde Peto, Jean-Claude Ansquer, Patrick Aubonnet, For The MacuFEN Study Investigators

Research output: Contribution to journalArticlepeer-review

15 Citations (Scopus)

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 mm(3) (within-group difference) after fenofibric acid treatment and by -0.11 mm(3) after placebo. The between-group comparison of the change was -0.25 mm(3) (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 mm(3), respectively, for within group difference after fenofibric acid and by -3.1 µm and -0.02 mm(3), 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.

Original languageEnglish
Pages (from-to)307-317
Number of pages11
JournalOphthalmic Epidemiology
Volume21
Issue number5
Early online date18 Aug 2014
DOIs
Publication statusEarly online date - 18 Aug 2014

Keywords

  • Anticholesteremic Agents
  • Diabetes Mellitus, Type 2
  • Diabetic Retinopathy
  • Double-Blind Method
  • Female
  • Fenofibrate
  • Humans
  • Macula Lutea
  • Macular Edema
  • Male
  • Middle Aged
  • Prospective Studies
  • Tomography, Optical Coherence
  • Triglycerides
  • Visual Acuity
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

Fingerprint

Dive into the research topics of 'Effects of fenofibric acid on diabetic macular edema: the MacuFen study'. Together they form a unique fingerprint.

Cite this