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T.S. Chang, I.Q. Tonnu, D.R. Globe, J. Fine; longitudinal changes in self–reported visual functioningin AMD patients In a randomized controlled Phase I/II trial of lucentisTM (ranizumab; rHuFAB v2) . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3098.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To determine the sensitivity of the National Eye Institute Visual Functioning Questionnaire–25 (NEI–VFQ 25) to longitudinal changes in disease severity and visual acuity in a cohort of 57 patients with primary or recurrent subfoveal neovascularization (CNV) secondary to AMD who participated in FVF2128g, a phase I/II randomized controlled clinical trial of LucentisTM (ranibizumab; rhuFab V2). Methods: The NEI VFQ–25 and angiographic and clinical measures of severity (assessed by fluorescein angiography, fundus photographs, and visual acuity) were obtained at baseline and 3 months. Fluorescein angiography and fundus photography were assessed by the Fundus Photograph Reading Center at the University of Wisconsin Medical School. The best corrected visual acuity score in the study eye was obtained using the ETDRS chart. Longitudinal changes in patient reported visual function, visual acuity, and severity of AMD were defined as the difference between scores at baseline and 3 months. Changes over the two time points were assessed for statistical significance using the paired t–test. Ordinary least squares regression was used to assess the associations between NEI –VFQ–25 scores and visual acuity and severity of disease measures. Results: Among these 57 patients, paired t–tests showed statistically significant increases in visual acuity (p=0.002), VFQ–25 composite (p=0.026), general vision (p=0.001), social functioning (p=0.051), and mental health (p=0.041) scores at 3 months. A statistically significant decrease in the area of blood and leakage was noted (p=0.006 and p=0.0002 respectively). In a model with age, gender, visual acuity, and area of blood and leakage as predictors, visual acuity was the only statistically significant predictor of the composite score, distant activities, and the mental health subscale scores (p<0.05) Conclusions: Improvements in clinical, angiographic, and self–reported visual functioning measures were noted. Visual acuity was a statistically significant predictor of changes in patient reported visual function. Although severity of disease (e.g., area of leakage) was not found to be a statistically significant predictor of VFQ–25 scores, this might be due to the small sample size. This study provides further evidence to suggest that the NEI VFQ–25 may be a useful measure of change in visual functioning in randomized clinical trials
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