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