Abstract | PURPOSE: 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.
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Authors | Pascale Massin, Tunde Peto, Jean-Claude Ansquer, Patrick Aubonnet, For The MacuFEN Study Investigators |
Journal | Ophthalmic epidemiology
(Ophthalmic Epidemiol)
Vol. 21
Issue 5
Pg. 307-17
(Oct 2014)
ISSN: 1744-5086 [Electronic] England |
PMID | 25133794
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticholesteremic Agents
- Triglycerides
- fenofibric acid
- Fenofibrate
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Topics |
- Anticholesteremic Agents
(therapeutic use)
- Diabetes Mellitus, Type 2
(drug therapy)
- Diabetic Retinopathy
(blood, diagnosis, drug therapy)
- Double-Blind Method
- Female
- Fenofibrate
(analogs & derivatives, therapeutic use)
- Humans
- Macula Lutea
(pathology)
- Macular Edema
(blood, diagnosis, drug therapy)
- Male
- Middle Aged
- Prospective Studies
- Tomography, Optical Coherence
- Triglycerides
(blood)
- Visual Acuity
(physiology)
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