April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Determinants Of Health-related Quality Of Life After Ranibizumab Therapy For Diabetic Macular Edema In The RESTORE Trial
Author Affiliations & Notes
  • Paul Mitchell
    Ophthalmology, University of Sydney, Sydney, Australia
  • Meghan Gallagher
    Novartis Pharma AG, Basel, Switzerland
  • Keith Tolley
    Tolley Health Economics, Buxton, United Kingdom
  • Francesco Bandello
    Ophthalmology, Univ Vita Salute - San Raffaele, Milan, Italy
  • Gabriela Burian
    Clin Dvlpm WSJ 790 1 20 7,
    Novartis Pharma AG, Basel, Switzerland
  • RESTORE Study Group
    Ophthalmology, University of Sydney, Sydney, Australia
  • Footnotes
    Commercial Relationships  Paul Mitchell, Novartis (C, R); Meghan Gallagher, Novartis (E); Keith Tolley, Tolley Health Economics (E); Francesco Bandello, Novartis (R); Gabriela Burian, Novartis (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 574. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : 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).

Methods: : 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.

Results: : 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.

Conclusions: : 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.

Clinical Trial: : http://www.clinicaltrials.gov NCT00687804

Keywords: quality of life • diabetic retinopathy • macula/fovea 
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