April 2014
Volume 55, Issue 13
ARVO Annual Meeting Abstract  |   April 2014
High visual acuity response with reduced number of ranibizumab injections in patients with diabetic macular edema: a post-hoc analysis of the RESTORE study
Author Affiliations & Notes
  • Philippe Margaron
    Iris Pharma, La Gaude, France
  • Clare Bailey
    Bristol Eye Hospital, Bristol, United Kingdom
  • Georg Spital
    Ophthalmology, Augenabteilung am St. Franziskus-Hospital Münster, Münster, Germany
  • James Warburton
    Novartis Pharma AG, Surrey, United Kingdom
  • Ronny Hashmonay
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships Philippe Margaron, Novartis (E); Clare Bailey, Alimera Sciences (F), Allergan (C), Allergan (F), Bayer (C), Bayer (F), Novartis (C), Novartis (F); Georg Spital, Alimera Sciences (R), Allergan (R), Bayer (R), Novartis (R), Pfizer (R); James Warburton, Novartis (E); Ronny Hashmonay, Novartis (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 1705. doi:
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      Philippe Margaron, Clare Bailey, Georg Spital, James Warburton, Ronny Hashmonay; High visual acuity response with reduced number of ranibizumab injections in patients with diabetic macular edema: a post-hoc analysis of the RESTORE study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1705.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: Data from patients with diabetic macular edema (DME) who achieved a high visual acuity (VA) response to ranibizumab treatment but with fewer injections than the total RESTORE study population were analyzed

Methods: The analysis included DME patients treated with ranibizumab 0.5 mg pro re nata with or without laser who completed the 12-month study (n=206). Best corrected VA data and number of ranibizumab injections administered in the high VA response subgroup relative to the total population were analyzed. High VA response was defined as a ≥10 early treatment diabetic retinopathy study (EDTRS) letter gain at Month 12. Relevant baseline characteristics were evaluated

Results: Eighty one (39%) of 206 completers gained 10 or more letters. The mean (±SD) injection number in the high VA response subgroup and the total population was 6.9 (±2.8) and 7.2 (±2.8), respectively, and the mean (±SD) VA gain was 15.1 (±4.9) and 7.5 (±8.4) ETDRS letters, respectively. Of the 81 patients with high VA response, 49 (24% of completers) required ≤8 injections (mean 5.1 ±1.8) for a VA gain of 15.3 (±5.2) letters at month 12. Furthermore, 32 of these 49 (16% of completers) required ≤6 injections (mean 4.0 ±1.1) for a similar VA gain (15.8 ±5.4 letters). Baseline characteristics, including VA, central retinal thickness, age, body mass index and Hb1Ac, were similar across the high VA response subgroups and the total population

Conclusions: Within the RESTORE study, almost one quarter of patients achieved a high VA response to ranibizumab while requiring on average just 4-5 injections in the first year of treatment. This observation supports an individualized therapeutic approach for the management of DME patients, who often have comorbidities and high risk of complications and in whom sufficient but not excessive anti-vascular endothelial growth factor treatment is therefore required. These data indicate that the baseline characteristics evaluated do not predict the number of injections required for high VA response; further analyses are ongoing

Keywords: 505 edema • 754 visual acuity  

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