Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: 5-year results of two randomized clinical trials with an open-label extension - TAP Report No. 8

Purpose: To report vision and safety outcomes up to 5 years from an extension of the Treatment of Age-related Macular Degeneration with Photodynamic Therapy (TAP) Investigation evaluating verteporfin therapy in patients with subfoveal choroidal neovascularization (CNV) in age-related macular degeneration. Methods: Patients who completed the 2-year randomized, placebo-controlled portion of the TAP Investigation could participate in the open-label extension study for an additional 3 years. Patients in the study extension received open-label verteporfin therapy in the study eye, fellow eye or both eyes, irrespective of original treatment assignment to placebo or verteporfin, if leakage from CNV was evident on fluorescein angiography. Follow-up visits occurred at 3-month intervals through to month 48, with a final follow-up visit at month 60. Results: Of the 402 verteporfin-treated patients in the randomized trials, 320 (80%) enrolled in the extension study; 193 (60%) of these completed the extension study up to 5 years. Patients received an average of approximately two treatments during the 3 years of the extension study. Seventy-seven (62%) of the 124 verteporfin-treated patients with predominantly classic lesions at baseline who enrolled in the extension completed the month 60 examination. Twenty-six (34%) of these 77 patients had lost 3 or more lines of visual acuity by month 24 and 27 (35%) had lost this amount of vision by month 60; the mean change in visual acuity from baseline was also similar at the month 24 and month 60 examinations (-1.5 and -1.6 lines, respectively). When visual acuity results were examined for all extension patients who received verteporfin at baseline, regardless of baseline lesion composition and extension study completion status, a similar pattern of visual acuity stabilization was evident. Few additional instances of infusion-related back pain or photosensitivity reactions were reported from month 24 to month 60. No additional safety issues were noted after bilateral treatment. Conclusions: Vision outcomes remained relatively stable from month 24 to month 60 even though the treatment rate was low during this period. The TAP Study Group identified no new safety concerns to preclude repeating verteporfin therapy as described in this study through 5 years.