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D.–U.G. Bartsch, I. Kozak, I. Falkenstein, A. Tammewar, R.R. Henry, P. Burke, L. Cheng, W.R. Freeman; Effect of Glitazone Therapy for Diabetes on Macular Thickness and Vision: Preliminary Safety Study . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5437.
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To evaluate the safety of glitazone treatment for diabetes. Recent reports in the literature suggest that oral glitazone treatment for diabetes may cause or exacerbate retinal edema (Colucciello M. Arch Ophthalmol 123, 1273–5, 2005). Our hypothesis was that glitazone treatment may have caused subclinical edema evidenced by an increase in retinal thickness and the reports of massive macular edema represented one end of this spectrum.
We conducted a prospective safety study of 30 subjects undergoing placebo–controlled masked treatment with pioglitazone for diabetes. To date, we have enrolled 23 subjects and 8 subjects have successfully completed both the baseline visit and 3 month visit. Patient treatment consisted of either insulin with placebo or insulin with pioglitazone. Dosing was 30 mg QD for 2 weeks and followed by a dose of 45 mg QD for 10 weeks. Vision was recorded by ETDRS chart at 4 m and retinal volume was assessed with optical coherence tomography (Stratus OCT) using the fast macular map and macular map protocol.
Two eyes were excluded due to poor scanfit at baseline. Of the remaining 14 eyes 7 showed a mild increase in macular volume 7 showed a mild decrease in macular volume as assessed by OCT fast macular map protocol. No eyes showed an increase of macular volume over 10%. Visual acuity change and macular volume change were correlated in 5 eyes and not correlated in 5 eyes. 4 eyes showed no change in either visual acuity or macular volume.
Adverse ocular reactions reported with glitazone treatment such as exacerbation in diabetic macular edema are rare and idiosyncratic events. A larger study would be indicated to determine the prevalence of glitazone induced diabetic macular edema but it is an uncommon event.
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