September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Achievement of ≥20/40 vision with ranibizumab in patients with diabetic macular edema: a post-hoc analysis of the RESTORE study
Author Affiliations & Notes
  • Victor Chong
    Oxford Eye Hospital, Oxford, United Kingdom
  • Jonathan Alsop
    Numerus Ltd, Wokingham, Berkshire, United Kingdom
  • Philippe Margaron
    Novartis Pharma AG, Basel, Switzerland
  • Paul Mitchell
    Department of Ophthalmology, Centre for Vision Research, Westmead Millennium Institute, The University of Sydney, Sydney, New South Wales, Australia
  • Footnotes
    Commercial Relationships   Victor Chong, Allergan, Irvine, CA, (C), Bayer HealthCare, Whippany, NJ (C), Bayer HealthCare, Whippany, NJ (R), Heidelberg, Ladenburg, Germany (R), Novartis, Basel, Switzerland (C), Novartis International AG, Basel, Switzerland (F), Novartis International AG, Basel, Switzerland (R), Quantel, New York, NY (C), Quantel, New York, NY (F); Jonathan Alsop, Novartis, Basel, Switzerland (F), Numerus Ltd (E); Philippe Margaron, Novartis Pharma AG, Basel, Switzerland (E); Paul Mitchell, Alcon (C), Alcon (R), Allergan (C), Allergan (R), Bayer (C), Bayer (R), Novartis Pharma AG (C), Novartis Pharma AG (R), Pfizer (C), Pfizer (R), Solvay (Abbott) (C), Solvay (Abbott) (R)
  • Footnotes
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Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2079. doi:
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      Victor Chong, Jonathan Alsop, Philippe Margaron, Paul Mitchell; Achievement of ≥20/40 vision with ranibizumab in patients with diabetic macular edema: a post-hoc analysis of the RESTORE study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2079.

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

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Abstract

Purpose : RESTORE, a Phase III, randomized, multicenter, 12-month core study and 24-month open-label extension study, assessed the efficacy and safety of ranibizumab (RBZ) in patients with visual impairment due to diabetic macular edema (DME). In this post-hoc analysis, we studied the proportion of patients who achieved ≥20/40 vision at Month 12 and at Month 36, according to whether they had ≥20/40 vision at baseline and Month 12, respectively.

Methods : We analysed the 343 patients who received study treatment and had at least one post-baseline BCVA measurement during the core study. Patients were randomized to one of three treatment groups at baseline: RBZ 0.5 mg (n=115), RBZ 0.5 mg + laser (n=118) and laser (n=110). The extension study comprised 240 patients, all of whom were eligible to receive RBZ 0.5 mg pro re nata (PRN) and laser PRN at the investigator’s discretion. 20/40 vision (or better) was defined as a best-corrected visual acuity (BCVA) score ≥69 letters in the study eye. Missing data were imputed using a last observation carried forward (LOCF) approach.

Results : Between baseline and Month 12, the proportion of patients achieving ≥20/40 vision increased by 26.9% (from 46.1% to 73.0%) with RBZ monotherapy, by 23.8% (from 38.1% to 61.9%) with RBZ + laser and by 6.3% (from 38.2% to 44.5%) with laser. RBZ was also superior to laser in the subset of patients with < 20/40 vision at baseline (n=203), in whom the proportion achieving ≥20/40 vision in the three treatment groups was 54.8%, 39.7% and 27.9%, respectively. Among patients entering the extension study, the proportion of patients achieving ≥20/40 vision at Month 36 varied by initial randomized treatment assignment, being highest with RBZ monotherapy (78.3%), intermediate with RBZ + laser (67.1%) and lowest with laser (60.0%). In the subset of patients with <20/40 vision at Month 12 (n=85), approximately one-third had achieved ≥20/40 vision at Month 36, irrespective of treatment in the core study.

Conclusions : The data suggest that, in comparison with laser photocoagulation treatment, early RBZ treatment offers the best chance of achieving ≥20/40 vision. Regardless of initial treatment, some patients may achieve ≥20/40 vision when switched to RBZ treatment.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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