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JI LimTAP Study Group; Results of an Open-label Extension Investigating Verteporfin Therapy for CNV Due to AMD - TAP Report No. 5 . Invest. Ophthalmol. Vis. Sci. 2002;43(13):981.
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Purpose: To report the results from an open-label extension evaluating verteporfin (Visudyne®, Novartis AG) therapy in AMD patients with classic-containing subfoveal CNV, and especially: 1) vision outcomes of patients with predominantly classic lesions, and 2) safety outcomes for all participants. Methods: Patients who completed 24 months of the TAP Investigation and in whom it was judged that verteporfin therapy for CNV might reduce the risk of further vision loss were enrolled into the TAP Extension. Methods were similar to those used in the TAP Investigation, except extension patients with fluorescein leakage from CNV received open-label verteporfin therapy irrespective of their treatment assignment (verteporfin or placebo) at baseline. Results: The enrolled participants included 124 (78%) of the 159 verteporfin-treated patients with lesions composed of predominantly classic CNV at baseline, of whom 105 (85%) completed the month 36 examination. Patients who completed the month 36 examination received an average of 1.5 treatments from the month 24 to the month 36 examination. Verteporfin-treated patients with predominantly classic CNV at baseline, who participated in the extension, were younger, and had better visual acuity at the month 24 examination compared with patients not in the extension. They were also more likely to have absence of fluorescein leakage from classic CNV, or no progression of classic CNV beyond the baseline boundaries of the lesion at the month 24 examination. A 15-letter score loss from baseline in the study eye occurred in 37 (37%) of these patients at the month 24 examination, compared with 44 (42%) at the month 36 examination, averaging 9.5- and 10-letter loss, respectively. No additional safety concerns were noted. Two patients originally assigned to placebo had acute severe vision decrease (loss of ≥20 letters of visual acuity within 7 days of treatment) during the extension. Conclusion: Vision outcomes remained relatively stable for verteporfin-treated patients with predominantly classic lesions from the month 24 to the month 36 examination. Caution in the interpretation of these results appears warranted in the absence of a comparison with an untreated group during the extension and because not all patients in the TAP Investigation participated in the TAP Extension.
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