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N.M. Bressler, P.J. Rosenfeld, J.I. Lim, VIM Study Group; A Phase II Placebo-Controlled, Double-Masked, Randomized Trial - Verteporfin in Minimally Classic CNV Due to AMD (VIM) . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1100.
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Purpose: To compare potential treatment benefit and safety of verteporfin (Visudyne®, Novartis AG) therapy and placebo for minimally classic subfoveal CNV due to AMD using a standard light dose and one delivered with reduced fluence rate. Methods: Patients (>50 years of age) with minimally classic lesions of <6 MPS disc areas (DA) (1 MPS DA=2.54mm2) in this double-masked study were randomized (1:1:1:) to one of three treatment groups: (1) verteporfin therapy with reduced light fluence rate (300 mW/cm2) for 83 seconds (25 J/cm2); (2) verteporfin therapy with standard light fluence rate (600 mW/cm2) for 83 seconds (50 J/cm2); (3) placebo; half with reduced and half with standard light fluence rate. Fluorescein and ICG angiography and best-corrected visual acuity were assessed 1 week after treatment in 10 patients from each group. All patients were assessed at 6 weeks, 3 months, and 6 months after initial visit. Changes in total area of the lesion and individual components were assessed through month 3 and change in visual acuity from baseline was assessed at all visits. Safety was evaluated by adverse events, visual acuity, fluorescein angiograms, and color fundus photographs. Results: 117 patients enrolled from 19 centers in North America and Europe. At baseline, main demographic variables did not appear different among treatment groups: overall, mean age 78, 64% women, mean study eye visual acuity (approximate Snellen equivalent) 20/100-1. At baseline, for the reduced fluence, standard fluence, and placebo groups, respectively: mean total lesion area was 3.65, 3.91, 3.25 MPS DA; mean area of occult CNV 3.28, 3.36, 2.89 MPS DA; and classic CNV 0.26, 0.41, 0.29 MPS DA. Six-month vision and fluorescein angiographic outcomes will be reported. Conclusions: Results from this trial may determine whether a phase III trial should compare one of these treatment arms with placebo for minimally classic lesions.
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