TY - JOUR
T1 - Verteporfin Therapy of Subfoveal Occult Choroidal Neovascularization in AMD Using Delayed Light Application
T2 - One-year Results of the VALIO Study
AU - Rosenfeld, Philip J.
AU - Boyer, David S.
AU - Bressler, Neil M.
AU - Fish, Gary
AU - Grizzard, W. Sanderson
AU - Hao, Yong
AU - Hnik, Peter
AU - Hudson, Henry L.
AU - Singerman, Lawrence
AU - Slakter, Jason S.
N1 - Funding Information:
This study was supported by Novartis Pharma AG, Basel, Switzerland, and QLT, Inc, Vancouver, British Columbia, Canada. The Johns Hopkins University, (but not Dr Bressler) is paid for consulting services provided by Dr 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 consultant to QLT, Inc, or Novartis Pharma AG, or both (which may also include travel expenses at meetings or participation in a speaker’s bureau): Drs Rosenfeld, Boyer, and Slakter. The following authors have indicated that they are or have received grant support from QLT, Inc, or Novartis Pharma AG, or both: Drs Rosenfeld and Singerman. The following authors own stocks or options in QLT, Inc, or Novartis Pharma AG, or both: Dr Slakter. Involved in design (P.J.R., D.S.B., Y.H., P.H.) and conduct of study (all); collection (all), management, analysis, and interpretation of the data (P.J.R., D.S.B., Y.H., P.H., J.S.S.); and preparation (P.J.R., Y.H., P.H.), review (P.J.R., D.S.B., Y.H., P.H., L.S., J.S.S.), or approval of the manuscript (all). This study was conducted according to the guidelines set forth in the Declaration of Helsinki. The design of the study, the protocol and amendment, and the informed consent form were reviewed and approved by an institutional review board or ethics committee at each study center before patient enrollment began. Before the start of any study procedures, all patients reviewed and signed a written informed consent form, which also conformed to current privacy regulations, with a certified investigator (ophthalmologist). This study was not registered on ClinicalTrials.gov because this was a phase 2 study that was completed before the ICMJE Statement on clinical trial registration came into effect in July 2005. Patients were enrolled in the study between December 4, 2001, and August 5, 2002, and the last patient completed the study by July 29, 2003.
PY - 2007/12
Y1 - 2007/12
N2 - Purpose: To compare photodynamic therapy (PDT) with verteporfin (Visudyne; Novartis Pharma AG, Basel, Switzerland) using either standard or delayed light application. Design: Phase II, multicenter, masked, randomized clinical trial. Methods: Sixty patients with occult with no classic choroidal neovascularization (CNV) resulting from age-related macular degeneration were assigned randomly (1:1) to verteporfin infusion followed by light application either at 15 minutes (standard light) or 30 minutes (delayed light) after the start of the infusion. The assigned treatment was repeated every three months if fluorescein leakage was detected. Results: At month 12, patients lost a mean of 15.7 letters and 11.4 letters from baseline in the standard and delayed light groups, respectively (P = .38). Twelve (52%) of 23 patients in the standard light group and 11 (42%) of 26 in the delayed light group lost at least 15 letters of visual acuity (P = .57). Conclusions: There were no statistically significant differences between verteporfin therapy using the delayed light regimen of 30 minutes or the standard light regimen of 15 minutes in eyes with occult with no classic CNV.
AB - Purpose: To compare photodynamic therapy (PDT) with verteporfin (Visudyne; Novartis Pharma AG, Basel, Switzerland) using either standard or delayed light application. Design: Phase II, multicenter, masked, randomized clinical trial. Methods: Sixty patients with occult with no classic choroidal neovascularization (CNV) resulting from age-related macular degeneration were assigned randomly (1:1) to verteporfin infusion followed by light application either at 15 minutes (standard light) or 30 minutes (delayed light) after the start of the infusion. The assigned treatment was repeated every three months if fluorescein leakage was detected. Results: At month 12, patients lost a mean of 15.7 letters and 11.4 letters from baseline in the standard and delayed light groups, respectively (P = .38). Twelve (52%) of 23 patients in the standard light group and 11 (42%) of 26 in the delayed light group lost at least 15 letters of visual acuity (P = .57). Conclusions: There were no statistically significant differences between verteporfin therapy using the delayed light regimen of 30 minutes or the standard light regimen of 15 minutes in eyes with occult with no classic CNV.
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U2 - 10.1016/j.ajo.2007.08.017
DO - 10.1016/j.ajo.2007.08.017
M3 - Article
C2 - 18036873
AN - SCOPUS:36249019912
SN - 0002-9394
VL - 144
SP - 970-972.e4
JO - American journal of ophthalmology
JF - American journal of ophthalmology
IS - 6
ER -