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G. Soubrane, VIP Study Group; Five–Year Results of Verteporfin Photodynamic Therapy in Pathologic Myopia: Third Year of an Open–Label Extension of the VIP Trial . Invest. Ophthalmol. Vis. Sci. 2004;45(13):2277.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To report the long–term safety and vision outcomes of an open–label extension study of verteporfin (Visudyne®, Novartis AG) photodynamic therapy in patients with subfoveal CNV secondary to pathologic myopia. Methods: Patients who completed the first year of the VIP Extension were followed through 60 months if they were judged to possibly benefit from further verteporfin photodynamic therapy. Patients received standard therapy, regardless of their original treatment assignment in the VIP Trial. Results: Of the 120 patients with pathologic myopia in the VIP Trial, 67 (83%) of 81 patients initially assigned to verteporfin and 29 (74%) of 39 patients initially assigned to placebo were enrolled in the extension. At the month 36 examination, 59 of the 67 patients originally assigned to verteporfin underwent a visual acuity assessment; the median visual acuity from baseline improved at month 36. Patients received a mean of 0.4 treatments during the third year and no new safety concerns were noted. Results through month 60 will be presented. Conclusions: Visual acuity remained stable and verteporfin photodynamic therapy was safe through the month 36 examination. Caution in the interpretation of these results is warranted in the absence of an untreated group during the extension and because not all patients in the VIP Trial participated in the extension study.
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