July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Comparison of Ranibizumab and Aflibercept in Patients with Neovascular Age-Related Macular Degeneration treated following a ‘Treat and Extend’ protocol: efficacy variables from the pre-specified 12-month interim analysis of the RIVAL study
Author Affiliations & Notes
  • Mark C Gillies
    Ophthalmology, University of Sydney, Sydney, New South Wales, Australia
  • Alex Hunyor
    Ophthalmology, University of Sydney, Sydney, New South Wales, Australia
  • Jennifer Arnold
    Marsden Eye Specialists, Parramatta, New South Wales, Australia
  • Francois Pecheur
    Novartis Pharmaceuticals, Australia, Sydney, New South Wales, Australia
  • Kathryn Underhill
    Novartis Pharmaceuticals, Australia, Sydney, New South Wales, Australia
  • Robyn H Guymer
    CERA, Sydney, New South Wales, Australia
  • Ian McAllister
    Lions Eye Institute, Perth, Western Australia, Australia
  • Footnotes
    Commercial Relationships   Mark Gillies, Allergan (F), Bayer (F), Novartis (F), Opthea (C), Roche (R); Alex Hunyor, Bayer (C), Novartis (C); Jennifer Arnold, Bayer (R), Novartis (R); Francois Pecheur, Novartis (E); Kathryn Underhill, Novartis (E); Robyn Guymer, Bayer (C), Genetech (C), Novartis (C), Roche (C); Ian McAllister, Bayer (C), Novartis (C)
  • Footnotes
    Support  This study was funded and sponsored by Novartis Pharmaceuticals Australia
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 840. doi:
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      Mark C Gillies, Alex Hunyor, Jennifer Arnold, Francois Pecheur, Kathryn Underhill, Robyn H Guymer, Ian McAllister; Comparison of Ranibizumab and Aflibercept in Patients with Neovascular Age-Related Macular Degeneration treated following a ‘Treat and Extend’ protocol: efficacy variables from the pre-specified 12-month interim analysis of the RIVAL study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):840.

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

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Abstract

Purpose : To report results of the pre-specified 12-month interim analysis of key secondary endpoints from the RIVAL study: number of injections and change in Best Corrected Visual Acuity (BCVA) from baseline at Month 12 in eyes with neovascular Age-Related Macular Degeneration (nAMD) treated with 0.5 mg ranibizumab (RBZ) or 2.0 mg aflibercept (AFL) using a ‘Treat and Extend’ regimen (T&E). The primary study endpoint will be the rate of development of Geographic Atrophy at 24 months in the 2 treatment groups

Methods : RIVAL is a 24-month, randomised, partially masked, multi-centre Phase IV study. 281 eyes were randomised 1:1 to RBZ or AFL arms. Following three initial monthly injections, patients entered the T&E phase which was controlled by a reading centre that was masked to treatment allocation.

Results : 278 patients (n=141 RBZ; n=137 AFL) were included in the interim analysis. Demographics and baseline characteristics were comparable between the two arms. The mean BCVA at Baseline was 65.3 letters (RBZ) vs. 65.1 letters (AFL). At Month 12, the mean BCVA for completers was 72.9 letters for RBZ (n=127) and 70.5 letters for AFL (n=121). When applying a random effects mixed model, the change from baseline at Month 12 was assessed to be +7.2 (95% CI: 5.5-8.8) for RBZ and +4.9 (95% CI: 3.1-6.6) for AFL. (p=0.063) The mean number of injections over 12 months was 9.7 injections in both arms.

Conclusions : This pre-planned interim analysis of key secondary endpoints from the RIVAL study showed that significant visual improvements were achieved at 12 months with both ranibizumab and aflibercept in nAMD patients, with similar number of injections using a T&E regimen.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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