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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.
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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.
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 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
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.
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