May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
Patient-Reported Visual Function Over 24 Months in Predominantly Classic Neovascular AMD: Results From ANCHOR, a Phase III Trial of Ranibizumab and Verteporfin PDT
Author Affiliations & Notes
  • S. G. Schwartz
    Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Naples, Florida
  • N. M. Bressler
    Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • J. T. Fine
    Genentech, Inc., South San Francisco, California
  • C. M. Dolan
    Genentech, Inc., South San Francisco, California
  • E. M. Yu
    Genentech, Inc., South San Francisco, California
  • J. F. Ward
    Genentech, Inc., South San Francisco, California
  • T. S. Chang
    Retina Institute of California, Pasadena, California
  • Footnotes
    Commercial Relationships S.G. Schwartz, Genentech, F; Pfizer, I; Novartis, R; N.M. Bressler, Acucela, Bausch & Lomb, Carl Zeiss Meditec, Genentech, Notal Vision, Novartis, OSI/Eyetech, Othera, QLT, Regeneron, TargeGen, F; J.T. Fine, Genentech, E; C.M. Dolan, Genentech, C; E.M. Yu, Genentech, E; J.F. Ward, Genentech, C; T.S. Chang, Genentech, F.
  • Footnotes
    Support Supported in part by NIH center grant P30-EY014801, and by an unrestricted grant to the University of Miami from Research to Prevent Blindness, New York, NY
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1822. doi:https://doi.org/
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      S. G. Schwartz, N. M. Bressler, J. T. Fine, C. M. Dolan, E. M. Yu, J. F. Ward, T. S. Chang; Patient-Reported Visual Function Over 24 Months in Predominantly Classic Neovascular AMD: Results From ANCHOR, a Phase III Trial of Ranibizumab and Verteporfin PDT. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1822. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose:
 

To examine the effects of ranibizumab (LucentisTM) on patient-reported visual function using the NEI-VFQ 25 through 24 months in subjects with predominantly classic subfoveal choroidal neovascularization in ANCHOR, a phase III clinical trial.

 
Methods:
 

The NEI-VFQ 25 was administered to subjects at baseline and months 1, 2, 3, 6, 9, 12, 18 and 24. Subjects were randomized 1:1:1 to verteporfin PDT, 0.3 mg, and 0.5 mg ranibizumab. Prior to completion, the study was amended so that subjects who had not yet completed the Month 23 visit were offered the option to choose 0.3 mg ranibizumab for the remainder of the trial. Visual function was assessed by change in mean score from baseline at month 12 and month 24 for each of the NEI-VFQ 25 subscales with last observation carried forward for missing values. The NEI-VFQ 25 subscales are scored from 0-100 and a positive difference represents improved functioning or reduced dependency. Near activities, distance activities and vision-related dependency were pre-specified as secondary efficacy endpoints.

 
Results:
 

Results for 12 months are shown. Results for months 18 and 24 to evaluate the longer term effects and any changes after 12 months are forthcoming and will be presented.*p<0.0001 vs. PDT**p<0.01 vs. PDT  

 
Conclusions:
 

In the ANCHOR trial, ranibizumab subjects reported, on average, greater improvements in patient-reported visual function than verteporfin PDT subjects for near activities, distance activities and vision-related dependency subscales of the NEI VFQ-25 at least through 12 months. These data are consistent with the patient-reported visual function results through month 12 in the Phase III MARINA trial, where results were sustained through 24 months, and support the visual acuity outcomes reported from ANCHOR favoring ranibizumab over verteporfin PDT.

 
Clinical Trial:
 

www.clinicaltrials.gov NCT00061594

 
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • clinical (human) or epidemiologic studies: outcomes/complications 
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