Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin - Two-year results of 2 randomized clinical trials - TAP report 2

Objective: To report 24-month vision and fluorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin (Visudyne; CIB A Vision Corp, Duluth, Ga) in patients with subfoveal choroidal neovascular ization (CNV) caused by age-related macular degeneration (AMD). Design: Two multicenter, double-masked, placebo-controlled, randomized clin ical trials. Setting: Twenty-two ophthalmology practices in Europe and North America. Participants: Patients with subfoveal CNV lesions caused by AMD with greate st linear dimension on the retina measuring 5400 mum or less, with evidence of classic CNV and best-corrected visual acuity (approximate Snellen equiv alent) between 20/40 and 20/200. Methods: The methods were similar to those described in our 1-year results, (1) with follow-up examinations beyond 1 year continuing every 3 months (ex cept for Photograph Reading Center evaluations, which occurred only at mont h 18 and month 24 examinations). During the second year, the same regimen ( with verteporfin or placebo as applied at baseline) was used if angiography showed fluorescein leakage from CNV. The primary outcome was the proportio n of eyes with fewer than 15 letters (approximately 3 lines) of visual acui ty loss at the month 24 examination, adhering to an intent-to-treat analysi s. The last observation was carried forward to impute for any missing data. Results: Three hundred fifty-one (87%) of 402 patients in the verteporfin g roup compared with 178 (86%) of 207 patients in the placebo group completed the month 24 examination. Beneficial outcomes with respect to visual acuit y and contrast sensitivity noted at the month 12 examination in verteporfin -treated patients we re sustained through the month 24 examination. At the month 24 examination for the primary outcome, 213 (53%) of 402 verteporfin- treated patients compared with 78 (38%) of 207 placebo-treated patients los t fewer than 15 letters (P<.001). In subgroup analyses for predominantly cl assic lesions (in which the area of classic CNV makes up at least 50% of th e area of the entire lesion) at baseline, 94 (59%) of 159 verteporfin-treat ed patients compared with 26 (31%) of 83 placebo-treated patients lost fewe r than 15 letters at the month 24 examination (P<.001). For minimally class ic lesions (in which the area of classic CNV makes up <50% but >0% of the a rea of the entire lesion) at baseline, no statistically significant differe nces in visual acuity were noted. Few additional photosensitivity adverse r eactions and injection site adverse events were associated with verteporfin therapy in the second year of follow-up. Conclusions: The visual acuity benefits of verteporfin therapy for AMD pati ents with predominantly classic CNV subfoveal lesions are safely sustained for 2 years, providing more compelling evidence to use verteporfin therapy for these cases. For AMD patients with subfoveal lesions that are minimally classic, there is insufficient evidence to warrant routine use of vertepor fin therapy.