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PK KaiserTAP and VIP Study Groups; Verteporfin Therapy for Neovascular AMD: Safety Data from the TAP Investigation and VIP Trial . Invest. Ophthalmol. Vis. Sci. 2002;43(13):612.
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Purpose: To present a detailed, combined analysis of three randomized, placebo-controlled, multicenter, double-masked trials of patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) to evaluate the safety of verteporfin (Visudyne®, Novartis AG) therapy. Methods: The analysis included two trials comprising the Treatment of AMD with Photodynamic therapy (TAP) Investigation (609 patients), and AMD patients in the Verteporfin in Photodynamic therapy (VIP) Trial (339 patients). Safety was evaluated primarily by reports of adverse events, and severe vision decrease (defined as a loss of at least 20 letters of visual acuity within 7 days of treatment). Patients were assigned randomly (2:1) to verteporfin therapy or placebo infusion with sham therapy. Results: A higher percentage of verteporfin-treated patients had subjectively reported clinically-relevant visual disturbance events, injection-site events, and infusion-related back pain (Table 1). Photosensitivity reactions were reported in 3.5% of verteporfin-treated patients in the TAP Investigation and one patient in each treatment group in the AMD arm of the VIP Trial. Severe vision decrease, confirmed by the treating ophthalmologist, occurred in 0.7% of verteporfin-treated patients in the TAP Investigation, and 4.9% in the AMD arm of the VIP Trial. Conclusion: Safety data from a large patient sample from three controlled clinical trials confirm the favorable benefit/risk ratio of verteporfin therapy in AMD patients. Table 1 View OriginalDownload SlideView OriginalDownload Slide
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