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J.B. Christoforidis, A.P. Adamis, D.J. D'Amico; Medical Treatment of Diabetic Macular Edema With Rofecoxib . Invest. Ophthalmol. Vis. Sci. 2005;46(13):391.
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Purpose: On a microscopic level, diabetic retinopathy appears to be an inflammatory–mediated disease. In an animal model of diabetic retinopathy, the use of non–steroidal anti–inflammatory drugs decreased several inflammatory markers of diabetic retinopathy. The purpose of this investigation was to see whether rofecoxib, a COX–2 non–steroidal antiinflammatory inhibitor would reverse or prevent the progression of diabetic macular edema. Methods: After approval from MEEI Human Studies Committee, nine eyes from 5 patients were followed for a period 6 months. Patients were treated with a daily 50 mg dose of rofecoxib and were followed initially and at periods of 6 weeks, 3 and 6 months. Testing parameters included ETDRS visual acuity, dilated fundus examination and optical coherence tomography at each visit and fluorescein angiography at baseline, 3 and 6 month visits. Results: There was no clinical or statistically significant improvement seen in ETDRS visual acuity, optical coherence tomography (6mm diameter macular volume and macular thickness) or on fluorescein angiography in this clinical series. Conclusions: In this small pilot study, there was no clinical improvement in visual acuity or decrease in macular edema with the use of rofecoxib. This could be explained by the dose level of rofecoxib, differences of inflammatory mechanisms in the production of diabetic retinopathy in an animal model versus the production of diabetic macular edema in humans, and the lack of a direct inhibitory effect of COX–2 inhibitors on anti–VEGF activity.
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