TY - JOUR
T1 - Verteporfin therapy of subfoveal choroidal neovascularization in pathologic myopia
T2 - 2-Year results of a randomized clinical trial - VIP report no. 3
AU - Blinder, Kevin J.
AU - Blumenkranz, Mark S.
AU - Bressler, Neil M.
AU - Bressler, Susan B.
AU - Donati, Guy
AU - Lewis, Hilel
AU - Lim, Jennifer I.
AU - Menchini, Ugo
AU - Miller, Joan W.
AU - Mones, Jordi M.
AU - Potter, Michael J.
AU - Pournaras, Constantin
AU - Reaves, Al
AU - Rosenfeld, Philip
AU - Schachat, Andrew P.
AU - Schmidt-Erfurth, Ursula
AU - Sickenberg, Michel
AU - Singerman, Lawrence J.
AU - Slakter, Jason S.
AU - Strong, H. Andrew
AU - Virgili, Gianni
AU - Williams, George A.
N1 - Funding Information:
Supported by Novartis Ophthalmics AG, Bülach, Switzerland, and QLT Inc., Vancouver, British Columbia, Canada.
Funding Information:
The Writing Committee, assuming authorship responsibility for VIP Report No. 3, includes the following: Kevin J Blinder, MD; Mark S Blumenkranz, MD; Neil M Bressler, MD; Susan B Bressler; Guy Donati, MD; Hilel Lewis, MD; Jennifer I. Lim; Ugo Menchini, MD; Joan W. Miller, MD; Jordi M. Mones, MD; Michael J. Potter, MD; Constantin Pournaras, MD; Al Reaves, PhD*; Philip Rosenfeld, MD; Andrew P. Schachat, MD; Ursula Schmidt-Erfurth, MD; Michel Sickenberg, MD; Lawrence J. Singerman, MD; Jason S. Slakter, MD; H. Andrew Strong, PhD*; Gianni Virgili, MD; George A. Williams, MD. *Members of the writing committee who are employees of Novartis Ophthalmics or QLT Inc., who sponsored the trial. Funding for the study described in this paper was provided by Novartis Ophthalmics and QLT Inc. Neil M. Bressler, MD has been paid as a consultant to Novartis Ophthalmics and QLT Inc. The terms of this agreement have been managed by the Johns Hopkins University in accordance with its conflict of interest policies. Susan B. Bressler, MD, Virgili Gianni, MD, Jennifer I. Lim, MD, Ugo Mencini, MD, Jordi M Monés, MD, Michael J. Potter, MD, Philip J. Rosenfeld, MD, Andrew P. Schachat, MD, Ursula Schmidt-Erfurth and George A. Williams, MD have received support for consultations, scientific presentations at meetings, and/or travel expenses. George A. Williams, MD has stock ownership in QLT Inc. Joan W. Miller, MD and Ursula Schmidt-Erfurth MD have indicated that they have a patent interest in verteporfin. Detailed statements are on file in the Journal office.
PY - 2003/4/1
Y1 - 2003/4/1
N2 - Purpose: To report 24-month vision and fluorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin in patients with subfoveal choroidal neovascularization (CNV) caused by pathologic myopia. Design and Setting: Multicenter, double-masked, placebo-controlled, randomized clinical trial at 28 ophthalmology practices in Europe and North America. Participants: Patients with subfoveal choroidal neovascular lesions caused by pathologic myopia measuring no more than 5400 μm and best-corrected visual acuity (approximate Snellen equivalent) of 20/100 or better. Methods: Similar to methods described for 1-year results with follow-up examinations beyond 1 year, continuing every 3 months (except Photograph Reading Center evaluations only at the month 24 examination). During the second year, the same regimen (with verteporfin or placebo as applied at baseline) was used if angiography showed fluorescein leakage from CNV. Main Outcome Measures: The primary outcome was the proportion of eyes with fewer than 8 letters (approximately 1.5 lines) of visual acuity loss at the month 24 examination, adhering to an intent-to-treat analysis and using the last observation carried forward method to impute for any missing data. Results: Seventy-seven of 81 patients (95%) in the verteporfin group, compared with 36 of 39 patients (92%) in the placebo group, completed the month 24 examination. At this time point, 29 of 81 verteporfin-treated patients (36%) compared with 20 of 39 placebo-treated patients (51%) lost at least 8 letters (P = 0.11). The distribution of change in visual acuity at the month 24 examination was in favor of a benefit for the cases assigned to verteporfin (P = 0.05). This included improvement by at least 5 letters (equivalent to at least 1 line) in 32 verteporfin-treated cases [40%] vs. five placebo-treated cases (13%) and improvement by at least 15 letters (equivalent to at least 3 lines) in 10 verteporfin-treated cases (12%) vs. zero placebo-treated cases. No additional photosensitivity adverse reactions or injection site adverse events were associated with verteporfin therapy in the second year of follow-up. Conclusions: Verteporfin therapy for subfoveal CNV caused by pathologic myopia safely maintained a visual benefit compared with a placebo therapy through 2 years of follow-up. Although the primary outcome was not statistically significantly in favor of verteporfin therapy at 2 years as it had been at 1 year of follow-up, the distribution of change in visual acuity at the month 24 examination was in favor of the verteporfin-treated group and showed that this group was more likely to have improved visual acuity through the month 24 examination. The VIP Study Group recommends verteporfin therapy for subfoveal CNV resulting from pathologic myopia based on both the 1- and 2-year results of this randomized clinical trial.
AB - Purpose: To report 24-month vision and fluorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin in patients with subfoveal choroidal neovascularization (CNV) caused by pathologic myopia. Design and Setting: Multicenter, double-masked, placebo-controlled, randomized clinical trial at 28 ophthalmology practices in Europe and North America. Participants: Patients with subfoveal choroidal neovascular lesions caused by pathologic myopia measuring no more than 5400 μm and best-corrected visual acuity (approximate Snellen equivalent) of 20/100 or better. Methods: Similar to methods described for 1-year results with follow-up examinations beyond 1 year, continuing every 3 months (except Photograph Reading Center evaluations only at the month 24 examination). During the second year, the same regimen (with verteporfin or placebo as applied at baseline) was used if angiography showed fluorescein leakage from CNV. Main Outcome Measures: The primary outcome was the proportion of eyes with fewer than 8 letters (approximately 1.5 lines) of visual acuity loss at the month 24 examination, adhering to an intent-to-treat analysis and using the last observation carried forward method to impute for any missing data. Results: Seventy-seven of 81 patients (95%) in the verteporfin group, compared with 36 of 39 patients (92%) in the placebo group, completed the month 24 examination. At this time point, 29 of 81 verteporfin-treated patients (36%) compared with 20 of 39 placebo-treated patients (51%) lost at least 8 letters (P = 0.11). The distribution of change in visual acuity at the month 24 examination was in favor of a benefit for the cases assigned to verteporfin (P = 0.05). This included improvement by at least 5 letters (equivalent to at least 1 line) in 32 verteporfin-treated cases [40%] vs. five placebo-treated cases (13%) and improvement by at least 15 letters (equivalent to at least 3 lines) in 10 verteporfin-treated cases (12%) vs. zero placebo-treated cases. No additional photosensitivity adverse reactions or injection site adverse events were associated with verteporfin therapy in the second year of follow-up. Conclusions: Verteporfin therapy for subfoveal CNV caused by pathologic myopia safely maintained a visual benefit compared with a placebo therapy through 2 years of follow-up. Although the primary outcome was not statistically significantly in favor of verteporfin therapy at 2 years as it had been at 1 year of follow-up, the distribution of change in visual acuity at the month 24 examination was in favor of the verteporfin-treated group and showed that this group was more likely to have improved visual acuity through the month 24 examination. The VIP Study Group recommends verteporfin therapy for subfoveal CNV resulting from pathologic myopia based on both the 1- and 2-year results of this randomized clinical trial.
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U2 - 10.1016/S0161-6420(02)01998-X
DO - 10.1016/S0161-6420(02)01998-X
M3 - Article
C2 - 12689884
AN - SCOPUS:0242500327
SN - 0161-6420
VL - 110
SP - 667
EP - 673
JO - Ophthalmology
JF - Ophthalmology
IS - 4
ER -