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

J. Arnold, I. Barbazetto, R. Birngruber, M. S. Blumenkranz, Susan B Bressler, Neil M Bressler, G. Donati, G. E. Fish, E. S. Gragoudas, P. Harvey, P. K. Kaiser, H. Lewis, J. W. Miller, J. M. Monés, M. J. Potter, C. J. Pournaras, A. P. Schachat, U. Schmidt-Erfurth, L. J. Singerman, H. A. StrongH. Van den Berg, G. A. Williams

Research output: Contribution to journalArticle

Abstract

Objective: To report 24-month vision and fiuorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, Ga) in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD). Design: Two multicenter, double-masked, placebo-controlled, randomized clinical trials. Setting: Twenty-two ophthalmology practices in Europe and North America. Participants: Patients with subfoveal CNV lesions caused by AMD with greatest linear dimension on the retina measuring 5400 μm or less, with evidence of classic CNV and best-corrected visual acuity (approximate Snellen equivalent) between 20/40 and 20/200. Methods: The methods were similar to those described in our 1-year results, with follow-up examinations beyond 1 year continuing every 3 months (except for Photograph Reading Center evaluations, which occurred only at month 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 proportion of eyes with fewer than 15 letters (approximately 3 lines) of visual acuity loss at the month 24 examination, adhering to an intent-to-treat analysis. The last observation was carried forward to impute for any missing data. Results: Three hundred fifty-one (87%) of 402 patients in the verteporfin group compared with 178 (86%) of 207 patients in the placebo group completed the month 24 examination. Beneficial outcomes with respect to visual acuity and contrast sensitivity noted at the month 12 examination in verteporfin-treated patients were 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 lost fewer than 15 letters (P0% of the area of the entire lesion) at baseline, no statistically significant differences in visual acuity were noted. Few additional photosensitivity adverse reactions 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 patients 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 verteporfin therapy.

Original languageEnglish (US)
Pages (from-to)198-207
Number of pages10
JournalArchives of Ophthalmology
Volume119
Issue number2
StatePublished - 2001
Externally publishedYes

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Choroidal Neovascularization
Photochemotherapy
Macular Degeneration
Randomized Controlled Trials
Visual Acuity
Placebos
verteporfin
Contrast Sensitivity
Fluorescein Angiography
Ophthalmology
Therapeutics
North America
Retina
Reading
Observation

ASJC Scopus subject areas

  • Ophthalmology

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Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin : Two-year results of 2 randomized clinical trials - TAP report 2. / Arnold, J.; Barbazetto, I.; Birngruber, R.; Blumenkranz, M. S.; Bressler, Susan B; Bressler, Neil M; Donati, G.; Fish, G. E.; Gragoudas, E. S.; Harvey, P.; Kaiser, P. K.; Lewis, H.; Miller, J. W.; Monés, J. M.; Potter, M. J.; Pournaras, C. J.; Schachat, A. P.; Schmidt-Erfurth, U.; Singerman, L. J.; Strong, H. A.; Van den Berg, H.; Williams, G. A.

In: Archives of Ophthalmology, Vol. 119, No. 2, 2001, p. 198-207.

Research output: Contribution to journalArticle

Arnold, J, Barbazetto, I, Birngruber, R, Blumenkranz, MS, Bressler, SB, Bressler, NM, Donati, G, Fish, GE, Gragoudas, ES, Harvey, P, Kaiser, PK, Lewis, H, Miller, JW, Monés, JM, Potter, MJ, Pournaras, CJ, Schachat, AP, Schmidt-Erfurth, U, Singerman, LJ, Strong, HA, Van den Berg, H & Williams, GA 2001, 'Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: Two-year results of 2 randomized clinical trials - TAP report 2', Archives of Ophthalmology, vol. 119, no. 2, pp. 198-207.
Arnold, J. ; Barbazetto, I. ; Birngruber, R. ; Blumenkranz, M. S. ; Bressler, Susan B ; Bressler, Neil M ; Donati, G. ; Fish, G. E. ; Gragoudas, E. S. ; Harvey, P. ; Kaiser, P. K. ; Lewis, H. ; Miller, J. W. ; Monés, J. M. ; Potter, M. J. ; Pournaras, C. J. ; Schachat, A. P. ; Schmidt-Erfurth, U. ; Singerman, L. J. ; Strong, H. A. ; Van den Berg, H. ; Williams, G. A. / Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin : Two-year results of 2 randomized clinical trials - TAP report 2. In: Archives of Ophthalmology. 2001 ; Vol. 119, No. 2. pp. 198-207.
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title = "Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: Two-year results of 2 randomized clinical trials - TAP report 2",
abstract = "Objective: To report 24-month vision and fiuorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, Ga) in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD). Design: Two multicenter, double-masked, placebo-controlled, randomized clinical trials. Setting: Twenty-two ophthalmology practices in Europe and North America. Participants: Patients with subfoveal CNV lesions caused by AMD with greatest linear dimension on the retina measuring 5400 μm or less, with evidence of classic CNV and best-corrected visual acuity (approximate Snellen equivalent) between 20/40 and 20/200. Methods: The methods were similar to those described in our 1-year results, with follow-up examinations beyond 1 year continuing every 3 months (except for Photograph Reading Center evaluations, which occurred only at month 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 proportion of eyes with fewer than 15 letters (approximately 3 lines) of visual acuity loss at the month 24 examination, adhering to an intent-to-treat analysis. The last observation was carried forward to impute for any missing data. Results: Three hundred fifty-one (87{\%}) of 402 patients in the verteporfin group compared with 178 (86{\%}) of 207 patients in the placebo group completed the month 24 examination. Beneficial outcomes with respect to visual acuity and contrast sensitivity noted at the month 12 examination in verteporfin-treated patients were 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 lost fewer than 15 letters (P0{\%} of the area of the entire lesion) at baseline, no statistically significant differences in visual acuity were noted. Few additional photosensitivity adverse reactions 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 patients 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 verteporfin therapy.",
author = "J. Arnold and I. Barbazetto and R. Birngruber and Blumenkranz, {M. S.} and Bressler, {Susan B} and Bressler, {Neil M} and G. Donati and Fish, {G. E.} and Gragoudas, {E. S.} and P. Harvey and Kaiser, {P. K.} and H. Lewis and Miller, {J. W.} and Mon{\'e}s, {J. M.} and Potter, {M. J.} and Pournaras, {C. J.} and Schachat, {A. P.} and U. Schmidt-Erfurth and Singerman, {L. J.} and Strong, {H. A.} and {Van den Berg}, H. and Williams, {G. A.}",
year = "2001",
language = "English (US)",
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TY - JOUR

T1 - Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin

T2 - Two-year results of 2 randomized clinical trials - TAP report 2

AU - Arnold, J.

AU - Barbazetto, I.

AU - Birngruber, R.

AU - Blumenkranz, M. S.

AU - Bressler, Susan B

AU - Bressler, Neil M

AU - Donati, G.

AU - Fish, G. E.

AU - Gragoudas, E. S.

AU - Harvey, P.

AU - Kaiser, P. K.

AU - Lewis, H.

AU - Miller, J. W.

AU - Monés, J. M.

AU - Potter, M. J.

AU - Pournaras, C. J.

AU - Schachat, A. P.

AU - Schmidt-Erfurth, U.

AU - Singerman, L. J.

AU - Strong, H. A.

AU - Van den Berg, H.

AU - Williams, G. A.

PY - 2001

Y1 - 2001

N2 - Objective: To report 24-month vision and fiuorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, Ga) in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD). Design: Two multicenter, double-masked, placebo-controlled, randomized clinical trials. Setting: Twenty-two ophthalmology practices in Europe and North America. Participants: Patients with subfoveal CNV lesions caused by AMD with greatest linear dimension on the retina measuring 5400 μm or less, with evidence of classic CNV and best-corrected visual acuity (approximate Snellen equivalent) between 20/40 and 20/200. Methods: The methods were similar to those described in our 1-year results, with follow-up examinations beyond 1 year continuing every 3 months (except for Photograph Reading Center evaluations, which occurred only at month 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 proportion of eyes with fewer than 15 letters (approximately 3 lines) of visual acuity loss at the month 24 examination, adhering to an intent-to-treat analysis. The last observation was carried forward to impute for any missing data. Results: Three hundred fifty-one (87%) of 402 patients in the verteporfin group compared with 178 (86%) of 207 patients in the placebo group completed the month 24 examination. Beneficial outcomes with respect to visual acuity and contrast sensitivity noted at the month 12 examination in verteporfin-treated patients were 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 lost fewer than 15 letters (P0% of the area of the entire lesion) at baseline, no statistically significant differences in visual acuity were noted. Few additional photosensitivity adverse reactions 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 patients 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 verteporfin therapy.

AB - Objective: To report 24-month vision and fiuorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, Ga) in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD). Design: Two multicenter, double-masked, placebo-controlled, randomized clinical trials. Setting: Twenty-two ophthalmology practices in Europe and North America. Participants: Patients with subfoveal CNV lesions caused by AMD with greatest linear dimension on the retina measuring 5400 μm or less, with evidence of classic CNV and best-corrected visual acuity (approximate Snellen equivalent) between 20/40 and 20/200. Methods: The methods were similar to those described in our 1-year results, with follow-up examinations beyond 1 year continuing every 3 months (except for Photograph Reading Center evaluations, which occurred only at month 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 proportion of eyes with fewer than 15 letters (approximately 3 lines) of visual acuity loss at the month 24 examination, adhering to an intent-to-treat analysis. The last observation was carried forward to impute for any missing data. Results: Three hundred fifty-one (87%) of 402 patients in the verteporfin group compared with 178 (86%) of 207 patients in the placebo group completed the month 24 examination. Beneficial outcomes with respect to visual acuity and contrast sensitivity noted at the month 12 examination in verteporfin-treated patients were 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 lost fewer than 15 letters (P0% of the area of the entire lesion) at baseline, no statistically significant differences in visual acuity were noted. Few additional photosensitivity adverse reactions 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 patients 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 verteporfin therapy.

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