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M.J. Elman, R.Z. Raden, A. Carrigan, M. Sloan, G. Williams, VIDME Study Group; Verteporfin In Treatment of Diabetic Macular Edema (VIDME) – 3–Month Results of a Phase I/II Placebo–Controlled Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3184.
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Purpose: To assess the safety of verteporfin (Visudyne®, Novartis AG) therapy in patients with diabetic macular edema using escalating light–dose regimens. Methods: This was a light–dose escalation study with three light doses (12.5, 25, and 50 J/cm2) delivered 15 or 30 minutes after the start of verteporfin infusion (6 mg/m2). At each light dose, patients were randomly assigned in a 2:2:1 ratio to verteporfin therapy, with light applied at either 15 or 30 minutes after the start of infusion; or placebo, with light applied 15 minutes after the start of infusion. The light–dose escalation was based on safety assessments for each light dose. Safety was the primary endpoint so all adverse events were assessed. Best–corrected visual acuity, fundus photography, fluorescein angiography, and optical coherence tomography were assessed at weeks 1, 4, and 12 after treatment. Results: Patients (25 verteporfin, 6 placebo) were enrolled at two centers. All patients completed the final month 3 examination. Age, gender, and type of diabetes were relatively evenly distributed between treatment groups at baseline, except for differences in mean visual acuity and retinal thickness characteristics. Treatment was well tolerated in all groups and no light–dose–related adverse events were observed. Two patients treated with the 12.5 J/cm2 light dose had serious ocular adverse events (vitreous hemorrhage and retinal artery occlusion), which were judged to be secondary to diabetic retinopathy and not treatment related. Changes from baseline in area of edema and retinal thickness showed large variability and no consistent trend between groups. Conclusions: The results suggest that all light–dose regimens examined were well tolerated in this patient population. Verteporfin therapy had no obvious effects on macular edema compared with placebo. These findings should be interpreted with caution because of the limited sample sizes in the treatment regimens studied.
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