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The ACCORD Eye Substudy

Walter T. Ambrosius, PhD; Ronald P. Danis, MD; David C. Goff Jr, MD, PhD; Craig M. Greven, MD; Hertzel C. Gerstein, MD, MSc; Robert M. Cohen, MD; Matthew C. Riddle, MD; Michael E. Miller, PhD; John B. Buse, MD, PhD; Denise E. Bonds, MD, MPH; Kevin A. Peterson, MD; Yves D. Rosenberg, MD; Letitia H. Perdue, BA; Barbara A. Esser, MS; Lea A. Seaquist, RN; James V. Felicetta, MD; Emily Y. Chew, MD; for the ACCORD Study Group

Arch Ophthalmol. 2010;128(3):312-318. doi:10.1001/archophthalmol.2009.310

Objective  To assess the cross-sectional association of thiazolidinediones with diabetic macular edema (DME).

Methods  The cross-sectional association of DME and visual acuity with thiazolidinediones was examined by means of baseline fundus photographs and visual acuity measurements from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Visual acuity was assessed in 9690 participants in the ACCORD trial, and 3473 of these participants had fundus photographs that were centrally read in a standardized fashion by masked graders to assess DME and retinopathy from October 23, 2003, to March 10, 2006.

Results  Among the subsample, 695 (20.0%) people had used thiazolidinediones, whereas 217 (6.2%) people had DME. Thiazolidinedione use was not associated with DME in unadjusted (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.71-1.44; P = .95) and adjusted (OR, 0.97; 95% CI, 0.67-1.40; P = .86) analyses. Significant associations with DME were found for retinopathy severity (P < .001) and age (OR, 0.97; 95% CI, 0.952-0.997; P = .03) but not for hemoglobin A_1c (P = .06), duration of diabetes (P = .65), sex (P = .72), and ethnicity (P = .20). Thiazolidinedione use was associated with slightly greater visual acuity (0.79 letter; 95% CI, 0.20-1.38; P = .009) of uncertain clinical significance.

Conclusions  In a cross-sectional analysis of data from the largest study to date, no association was observed between thiazolidinedione exposure and DME in patients with type 2 diabetes; however, we cannot exclude a modest protective or harmful association.

Trial Registration  clinicaltrials.gov Identifier: NCT00542178

Author Affiliations: Departments of Biostatistical Sciences (Drs Ambrosius and Miller and Ms Perdue), and Epidemiology and Prevention (Dr Goff), Division of Public Health Sciences, and Department of Ophthalmology (Dr Greven), Wake Forest University School of Medicine, Winston-Salem, North Carolina; Fundus Photograph Reading Center, Department of Ophthalmology, University of Wisconsin, Madison (Dr Danis and Ms Esser); McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada (Dr Gerstein); Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, University of Cincinnati Medical Center, Cincinnati, Ohio (Dr Cohen); Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Medicine, Oregon Health and Science University, Portland (Dr Riddle); Department of Medicine, University of North Carolina School of Medicine, Chapel Hill (Dr Buse); Divisions of Prevention and Population Sciences (Dr Bonds) and Cardiovascular Diseases (Dr Rosenberg), National Heart, Lung, and Blood Institute, and Division of Epidemiology and Clinical Applications, National Eye Institute (Dr Chew), National Institutes of Health, Bethesda, Maryland; Department of Family Medicine and Community Health, Medical School, University of Minnesota, Minneapolis (Dr Peterson and Ms Seaquist); and Phoenix VA Health Care System, Phoenix, Arizona (Dr Felicetta).
Group Information: A list of the ACCORD Study Group investigators was published in AM J Cardiol. 2007;99(12)(suppl):S4-S20.

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Arch Ophthalmol. 2010;128(12):1630-1631.
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