Health Related Quality of Life In Ranibizumab treatment for Diabetic Macular Oedema: Novel Findings From The RESTORE Trial

1. Paul Mitchell¹
2. Keith Tolley²
3. Meghan Gallager³

¹University of Sydney (Centre for Vision Research, Westmead Millennium Institute), Australia
²Tolley Health Economics, London, UK
³Novartis Pharma AG, Basel, Switzerland

Purpose: To assess the impacts on health related quality of life (HRQoL) of ranibizumab treatment for diabetic macular oedema (DME) in the Phase III RESTORE trial, comparing ranibizumab monotherapy (R) to laser alone (L) or combined ranibizumab/laser therapy (R+L).

Methods: The National Eye Institute Visual Functioning questionnaire (NEI-VFQ, 25 items) was administered at baseline, 3 months and 12 months; results coded into General Vision, Near Vision, Distance Activities and Composite scores.

Results: For the General Vision scale, the baseline to 1-year mean gain was 7.8 units for R (p<0.001), 6.9 units for R+L (p<0.05), over L. Near Vision 1-year mean gains were 7.9 (R) and 8.0 (R+L) units over L, respectively; similar increases as in pivotal AMD trials. Although greater visual acuity gains over laser were found for more than less severe vision loss (≤6/15 vs >6/15), patients with less severe vision loss 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: Significant 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.