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P. Lanzetta, ANCHOR and PIER Study Groups; Ranibizumab and Patient-Reported Outcomes: VFQ-25 Data From the ANCHOR and PIER Trials in Patients With Neovascular AMD. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5571. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
Recently published data from the MARINA trial have shown that monthly 0.3 or 0.5 mg ranibizumab improves patient-reported visual function, assessed using the National Eye Institute VFQ-25 questionnaire, in patients with neovascular age-related macular degeneration (AMD) with minimally classic or occult lesions (Chang et al. Arch Ophthalmol 2007; 125: 1460-69). From baseline to Month 24, near activity, distance-activity, and vision-specific dependency mean scores increased with ranibizumab 0.5 mg (8.9, 5.7, and 6.0, respectively), but decreased with sham (-6.7, -8.4, and -10.5, respectively). Here we further examine the impact of ranibizumab therapy on quality of life in patients with neovascular AMD by analyzing data from two other Phase III trials.
ANCHOR: patients with predominantly classic lesions (n=423) were treated monthly with 0.3 mg or 0.5 mg ranibizumab or quarterly with verteporfin photodynamic therapy for two years. PIER: patients with all types of choroidal neovascularization (CNV) lesions (n=184) were treated with 0.3 mg or 0.5 mg ranibizumab or sham monthly for the first three months then once every three months for two years. Both trials included the following VFQ-25 subscales as predefined secondary endpoints: near activity, distance activity and vision-specific dependency.
Significant improvements from baseline were observed in all three VFQ-25 subscale scores for both ranibizumab doses evaluated in the ANCHOR trial. These improvements, first seen at six months, were maintained throughout the two-year study period. At Month 24, near-activity, distance-activity, and vision-specific dependency mean scores for 0.5 mg ranibizumab increased from baseline by 7.1, 5.7, and 6.0 respectively. PIER trial data showed an initial improvement in VFQ-25 mean scores, which gradually decreased over time to the baseline level with the quarterly dosing regimen; at one-year, changes in near activity, distance activity and vision-specific dependency scores for 0.5 mg were 0.1, -0.6, and -2.7 respectively.
Two-year results from ANCHOR confirm previous observations from MARINA that ranibizumab is associated with improvements in patient-reported perception of ability to perform daily living tasks. As previously shown, the results are clinically relevant and confirm the association of 5-10 point change in VFQ-25 scores with a 3-line gain in visual acuity (VA) outcomes. The VFQ-25 scores of PIER follow the VA outcomes obtained with the quarterly dosing regimen and show that this fixed dosing regimen was not optimal.
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