Verteporfin Therapy for Subfoveal Choroidal Neovascularization in Age-Related Macular Degeneration

2002 Archives of Ophthalmology  
Objective: To report vision and safety outcomes from an extension of a 2-year investigation evaluating verteporfin photodynamic therapy in patients with agerelated macular degeneration with subfoveal choroidal neovascularization (CNV). Design and Setting: Open-label extension of selected patients from 2 multicenter, double-masked, placebo-controlled, randomized clinical trials, the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Investigation, at 22 ophthalmology
more » ... actices in Europe and North America. Participants: Patients enrolled in the TAP Investigation and followed up for at least 24 months in whom verteporfin therapy to CNV might reduce the risk of further vision loss. Methods: Before receiving verteporfin therapy in the extension, eligible patients signed a written informed consent form accompanied by an oral consent process approved by local institutional review boards. Methods were similar to those described for 1-and 2-year results, with follow-up examinations beyond 2 years continuing at 3-month intervals with a few exceptions, including that extension patients with fluorescein leakage from CNV were to receive open-label verteporfin therapy irrespective of their original treatment assignment. Results: Of 402 patients in the verteporfin group, 351 (87.3%) completed the month 24 examination; 320 (91.2%) of these enrolled in the extension study. The enrolled par-ticipantsincluded124(78.0%)ofthe159verteporfin-treated patients with lesions composed of predominantly classic CNVatbaseline,of whom105(84.7%)completedthemonth 36 examination. Verteporfin-treated patients with this lesion composition at baseline who participated in the extension study, with or without a month 36 examination, appeared more likely to have a younger age, better level of (REPRINTED) ARCH OPHTHALMOL / VOL 120, OCT 2002 WWW.ARCHOPHTHALMOL.COM 1307 Month 24 Follow-up (n = 121 [97.6%]) Received Treatment: n = 50 (40.3%) No Treatment Because No CNV Leakage (Study Eye): n = 67 (55.4%) Month 27 Follow-up (n = 118 [95.2%]) Received Treatment: n = 42 (33.9%) No Treatment Because No CNV Leakage (Study Eye): n = 76 (64.4%) Month 30 Follow-up (n = 111 [89.5%]) Received Treatment: n = 29 (23.4%) No Treatment Because No CNV Leakage (Study Eye): n = 78 (70.3%) Month 33 Follow-up (n = 105 [84.7%]) Received Treatment: n = 23 (18.5%) No Treatment Because No CNV Leakage (Study Eye): n = 81 (77.1%) Month 36 Follow-up (n = 105 [84.7%]) Received Treatment: n = 24 (19.4%) No Treatment Because No CNV Leakage (Study Eye): n = 79 (75.2%)
doi:10.1001/archopht.120.10.1307 pmid:12365909 fatcat:6g6butvnuvgpxbivak5bv7nwgm