title: Effects of fenofibric acid on diabetic macular edema: the MacuFen study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Hôpital Lariboisière , Paris , France .
authors.forename: Pascale
authors.initials: P
authors.lastname: Massin
authors.forename: Tunde
authors.initials: T
authors.lastname: Peto
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Ansquer
authors.forename: Patrick
authors.initials: P
authors.lastname: Aubonnet
authors.forename: For The
authors.initials: FT
authors.lastname: MacuFEN Study Investigators
mesh_terms: D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D003930:Diabetic Retinopathy / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D011345:Fenofibrate / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008266:Macula Lutea / Q000473:pathology; D008269:Macular Edema / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D014280:Triglycerides / Q000097:blood; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000924:Anticholesteremic Agents; D014280:Triglycerides; C006012:fenofibric acid; D011345:Fenofibrate
keywords: Diabetic macular edema; dyslipidemia; fenofibric acid; optical coherence tomography; type 2 diabetes mellitus