Abstract
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.
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References
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Financial disclosure:
The Johns Hopkins University, but not Dr. N. Bressler, is paid for consulting services provided by Dr. N. Bressler to Novartis Pharma AG and QLT Inc. The terms of this institutional consulting arrangement are being managed by the Johns Hopkins University in accordance with its conflict of interest policies. The following authors have indicated that they are or have been paid as consultants to QLT Inc. or Novartis Pharma AG or both (which may also include travel expenses at meetings or participation in a speakers bureau): Andrea Wenkstern, MD; Jason S. Slakter, MD. The following authors have indicated support for travel expenses at meetings or participation in a speaker’s bureau: Michael J. Potter, MD; Philip J. Rosenfeld, MD, PhD; Peter K Kaiser, MD; Joan W. Miller, MD. Joan W. Miller, MD and Ursula Schmidt-Erfurth, MD, PhD have a patent interest in verteporfin under the guidelines of the Massachusetts General Hospital/Harvard Medical School. Detailed statements are on file with the Chair of the Verteporfin Study Advisory Group’s office.
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Reprint requests: Novartis Ophthalmics Medical Affairs, One Health Plaza, Building 104, East Hanover, NJ 07936, USA
Financial/proprietary interest: financial interests of Writing Committee members, who bear author responsibility for this report, are listed at the end of this article
A complete list of the participants in the Treatment of Age-related Macular Degeneration Study Group is available in Arch Ophthalmol 1999; 117:1329–1345, with updates in Arch Ophthalmol 2001;119:198–207
The following individuals take authorship responsibility for TAP Report No. 8
The following individuals take authorship responsibility for TAP Report No. 8
Peter K. Kaiser, MD (Writing Committee Chair), Cole Eye Institute, The Cleveland Clinic Foundation, Cleveland, OH, USA
Neil M. Bressler, MD, The Wilmer Ophthalmological Institute, Johns Hopkins University, Baltimore, MD, USA
Gary E. Fish, MD, Texas Retina Associates, Dallas, TX, USA
Laurie Haynes, MA, ELS*, QLT Inc., Vancouver, BC, Canada
Joan W. Miller, MD, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, MA, USA
Joel Naor, MD*, QLT Inc., Vancouver, BC, Canada
Michael J. Potter, MD, UBC Department of Ophthalmology & Visual Sciences, Eye Care Centre (VGH), Vancouver, BC, Canada
Constantin Pournaras, MD, Hôpital Cantonal Universitaire de Genève, Geneva, Switzerland
Philip J. Rosenfeld, MD, PhD, Bascom Palmer Eye Institute, Miami, FL, USA
Ursula Schmidt-Erfurth, MD, University Eye Hospital, Vienna, Austria
Jason S. Slakter, MD, LuEsther T. Mertz Retinal Research Center, Manhattan Eye, Ear & Throat Hospital, New York, NY, USA
H. Andrew Strong, PhD*, QLT Inc., Vancouver, BC, Canada
Yong Hao, MD, PhD*, QLT Inc., Vancouver, BC, Canada
Stéphane Vannier*, QLT Inc., Vancouver, BC, Canada
Andrea Wenkstern, MD, Augen Glattzentrum AG, Zurich, Switzerland
Annemarie Weisberger, MD*, Novartis Pharmaceuticals Corp., East Hanover, NJ, USA
We acknowledge Christy V. Costello, ELS*, who provided editing assistance.
* Members of the Writing Committee who are employees of Novartis Pharma AG or QLT Inc., which sponsored the trial.
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Kaiser, P.K., Treatment of Age-related Macular Degeneration with Photodynamic Therapy (TAP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: 5-year results of two randomized clinical trials with an open-label extension. Graefe's Arch Clin Exp Ophthalmo 244, 1132–1142 (2006). https://doi.org/10.1007/s00417-005-0199-9
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DOI: https://doi.org/10.1007/s00417-005-0199-9