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G. Zlateva, M. Patel, S.N. Shah, VEGF Inhibition Study in Ocular Neovascularization(V.I.S.I.O.N. ) Clinical Trial Group; Quality of Life in Patients with Age–related Macular Degeneration: Results from the VISION Study . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2152.
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© ARVO (1962-2015); The Authors (2016-present)
To investigate the impact of treatment with Macugen and usual care on health–related quality of life (QOL) in patients with age–related macular degeneration (AMD) in a longitudinal study.
The impact of QOL for patients with neovascular AMD was assessed as a secondary endpoint in a subgroup of patients in the VISION trial, a prospective, randomized, double–masked, multicenter, dose–ranging study. Three doses of pegaptanib sodium (0.3, 1.0, 3.0 mg) were compared with sham with respect to the change in visual functioning as indicated by the National Eye Institute Visual Function Questionnaire 25 (NEI–VFQ 25). Patients were asked to complete the NEI–VFQ 25 at Baseline, Week 30 and Week 54. From the 12 subscales of NEI–VFQ, 4 were prospectively designated as primary: Near Vision, Distance Vision, Role Limitations, and Dependency. Between group differences were assessed for each domain of the NEI–VFQ 25 using an ANCOVA model with age, gender, and baseline score as covariates.
NEI–VFQ data was available on 569 subjects, equally distributed among the 4 study arms. Although patients were similar in many characteristics, proportion of patients with best eye treated was largest in the sham group (45%) compared to the 0.3, 1.0, and 3.0 mg treatment groups with 40%, 40% and 35% respectively. The active treatment groups demonstrated significantly better outcomes on several domains compared with the sham group. The Distance Vision and Role Limitations domains were consistently better with active treatment. The LS Means score differences between 0.3, 1.0, 3.0 mg and sham on Distance Vision were similar, 4.3 (p=0.059), 4.63 (0.041), and 5.83 (0.011). Other subscales demonstrating improvement over sham across all 3 doses were Social Functioning, Color Vision, and Peripheral Vision. Analysis of responders, i.e. patients losing <15 letters at 54 weeks, and non–responders, i.e. patients losing >15 letters, showed a statistically significant benefit for the responders in 8 of the 12 NEI–VFQ subscales, including the primary 4.
The VISION study provided evidence of trends in quality of life benefit associated with effective treatment of AMD using pegaptanib sodium. All three active doses were similar in their effect, although the lack of statistically significant differences in some of the scale scores may have been due, in part, to the small group size. Additionally, a majority of patients enrolled had their worse eye treated, while VFQ–25 scores depend more upon the vision status of the better eye than the worse eye. Treatment with pegabtanib sodium is expected to contribute significantly to QOL improvement for responder patients.
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