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Paul Mitchell, Meghan Gallagher, Keith Tolley, Francesco Bandello, Gabriela Burian, RESTORE Study Group; Determinants Of Health-related Quality Of Life After Ranibizumab Therapy For Diabetic Macular Edema In The RESTORE Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):574.
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To describe the impact on Health-Related Quality of Life (HRQoL) and its determinants from Ranibizumab therapy for diabetic macular edema (DME) in the RESTORE Phase III randomized clinical trial (RCT). This RCT compared ranibizumab monotherapy (Ranibizumab) to laser alone (Laser) or combined ranibizumab/ laser therapy (Combined).
The National Eye Institute Visual Functioning questionnaire (NEI-VFQ, 25 items) was administered at baseline, and at 3 months and 12 months. The results were coded into General Vision, Near Vision, Distance Activities and Composite scores.
For the General Vision scale, the baseline to 1-year mean gain over Laser was 7.8 VFQ units for Ranibizumab (p<0.0001) and 6.9 units for Combined (p<=0.001). Near Vision 1-year mean VFQ unit gains over Laser were 7.9 for Ranibizumab and 8.0 for Combined, p=0.001 and p=0.006, respectively. The magnitude of these NEI-VFQ increases was similar to the increases in HRQoL documented in the pivotal AMD trials (MARINA, ANCHOR) associated with Ranibizumab therapy. Although greater visual acuity gains over laser were found for more severe than for less severe vision impairment (≤6/15 vs >6/15), patients with less severe vision impairment had around double the NEI-VFQ25 score gains on the General and Near scales than those with more severe loss. Similarly, while greater VA gains over laser were found in patients with more than less severe retinal thickening (CRT≥400µm vs CRT<400µm), those with less than more severe CRT thickness also had close to double the VFQ25 gains.
Clinically meaningful HRQoL benefits were associated with ranibizumab therapy for DME. Greater magnitude gains were seen in patients with less compared with more severe disease suggesting most benefit if vision is 'restore'd to good function (i.e. reading, shopping, driving). It may also indicate more severe disease reflects chronicity and less reversibility.
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