May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
Self-Reported Perception of Driving Function Following Ranibizumab Treatment in Patients With Neovascular AMD
Author Affiliations & Notes
  • T. S. Chang
    Retina Institute of California, Pasadena, California
  • N. M. Bressler
    Retina Division, Wilmer Eye Institute, John 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
  • J. Ward
    Genentech, Inc, South San Francisco, California
  • Footnotes
    Commercial Relationships T.S. Chang, Genentech, Inc., C; Novartis, C; Regeneron, C; N.M. Bressler, Acucela, F; Bausch and Lomb, F; Carl Zeiss Meditec, F; Genentech, F; Notal Vision Inc, F; Novartis, F; Novartis, F; Eyetech, F; Othera, F; QLT, F; Regeneron, F; TargeGen, F; J.T. Fine, Genentech, Inc, E; C.M. Dolan, Genentech, Inc, C; J. Ward, Genentech, Inc, C.
  • Footnotes
    Support None.
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1830. doi:https://doi.org/
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      T. S. Chang, N. M. Bressler, J. T. Fine, C. M. Dolan, J. Ward; Self-Reported Perception of Driving Function Following Ranibizumab Treatment in Patients With Neovascular AMD. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1830. 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 perception of driving function in subjects with subfoveal choroidal neovascularization due to age-related macular degeneration (AMD), in MARINA, a phase III randomized, controlled, double-masked trial of ranibizumab.

 
Methods:
 

In MARINA, subjects were randomized 1:1:1 to monthly sham injection (n=238) or injection with 0.3 mg (n=238) or 0.5 mg ranibizumab (n=240), with only one eye per patient receiving treatment. Driving status and self-reported perception of driving function were measured by the NEI VFQ-25, although not defined, a priori, as key subscales to assess efficacy of ranibizumab. Mean change in NEI VFQ-25 subscale scores from baseline at month 12 and 24 were compared between sham and the 0.5 mg treatment group. The NEI-VFQ-25 subscales are scored from 0-100 and a positive difference represents improved function.

 
Results:
 

At baseline, 69.7% of sham treated subjects and 68.3% of 0.5 mg ranibizumab treated subjects reported that they were still driving. At month 12 and 24, respectively, 52.4% and 49.5% of sham treated subjects compared to 64.4% and 57.7%, respectively of the 0.5 mg ranibizumab treated subjects reported that they were still driving. Changes in the NEI VFQ-25 driving subscale are presented below.MARINA: Change in Driving Function Subscale of the NEI VFQ-25 at 12 and 24 months*ranibizumab 0.5 mg vs. sham, p<0.0001  

 
Conclusions:
 

At 12 and 24 months, fewer sham treated subjects reported that they were still driving compared to ranibizumab treated subjects. Additionally, perception of driving function, as measured by the NEI VFQ-25 was decreased more for the sham subjects over 24 months compared to ranibizumab treated subjects. While it was not anticipated at the start of this trial that the effect on these outcomes would be so strong, these results suggest that ranibizumab may have an important impact on patient reported vision-related driving function.

 
Clinical Trial:
 

www.clinicaltrials.gov NCT00056836

 
Keywords: age-related macular degeneration • perception 
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