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

Abstract

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 practices 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

Recent developments in age-related macular degeneration: a review

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Recent developments in age-related macular degeneration: a review

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Pharmacokinetics and Pharmacodynamics Modeling and Simulation Systems to Support the Development and Regulation of Liposomal Drugs

“…Verteporfin was encapsulated in liposomes and utilized as a photosensitizer in photodynamic therapy to selectively eradicate abnormal blood vessels in the eye. The therapeutic benefits of liposomal verteporfin can last for at least 24 months without safety-related challenges when treating age-related macular degeneration [68]. The systemic clearance of verteporfin was not seen to be significantly influenced by the liposome formulation in a biodistribution study [69].…”

Age-Related Macular Degeneration: Advances in Management and Diagnosis

“…Eyes with predominantly classic lesions on fluorescein angiography benefited the most (67% vs. 39%; p < 0.001). The effects were sustained at two years [63] and three years [64]. …”

Recent developments in age-related macular degeneration: a review

“……”

Pharmacokinetics and Pharmacodynamics Modeling and Simulation Systems to Support the Development and Regulation of Liposomal Drugs

“…Verteporfin was encapsulated in liposomes and utilized as a photosensitizer in photodynamic therapy to selectively eradicate abnormal blood vessels in the eye. The therapeutic benefits of liposomal verteporfin can last for at least 24 months without safety-related challenges when treating age-related macular degeneration [68]. The systemic clearance of verteporfin was not seen to be significantly influenced by the liposome formulation in a biodistribution study [69].…”

Age-Related Macular Degeneration: Advances in Management and Diagnosis

“…Eyes with predominantly classic lesions on fluorescein angiography benefited the most (67% vs. 39%; p < 0.001). The effects were sustained at two years [63] and three years [64]. …”

Recent developments in age-related macular degeneration: a review

“……”

Pharmacokinetics and Pharmacodynamics Modeling and Simulation Systems to Support the Development and Regulation of Liposomal Drugs

“…Verteporfin was encapsulated in liposomes and utilized as a photosensitizer in photodynamic therapy to selectively eradicate abnormal blood vessels in the eye. The therapeutic benefits of liposomal verteporfin can last for at least 24 months without safety-related challenges when treating age-related macular degeneration [68]. The systemic clearance of verteporfin was not seen to be significantly influenced by the liposome formulation in a biodistribution study [69].…”

Age-Related Macular Degeneration: Advances in Management and Diagnosis

“…Eyes with predominantly classic lesions on fluorescein angiography benefited the most (67% vs. 39%; p < 0.001). The effects were sustained at two years [63] and three years [64]. …”