September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Clinical outcomes of treatment switching in neovascular age-related macular degeneration (nAMD): a retrospective cohort study in the United States (US) using electronic medical records
Author Affiliations & Notes
  • Frances Milnes
    Novartis Pharma AG, Basel, Switzerland
  • Raymond Griner
    IMS Health Inc., Burlington, Massachusetts, United States
  • Alberto Ferreira
    Novartis Pharma AG, Basel, Switzerland
  • Adrian Skelly
    Novartis Ireland Limited, Dublin, Ireland
  • Pravin U Dugel
    Retinal Consultants of Arizona, Phoenix, Arizona, United States
  • Footnotes
    Commercial Relationships   Frances Milnes, Novartis Pharma AG (E); Raymond Griner, IMS Health Inc. (E); Alberto Ferreira, Novartis Pharma AG (E); Adrian Skelly, Novartis Ireland Limited (E); Pravin Dugel, Alcon (C), Genentech (C), Novartis (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3365. doi:
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      Frances Milnes, Raymond Griner, Alberto Ferreira, Adrian Skelly, Pravin U Dugel; Clinical outcomes of treatment switching in neovascular age-related macular degeneration (nAMD): a retrospective cohort study in the United States (US) using electronic medical records. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3365.

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

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Abstract

Purpose : To compare best corrected visual acuity (BCVA letter score) outcomes in nAMD pre- and post- ranibizumab and aflibercept treatment switch in a real-world setting.

Methods : Data were extracted from 53 retina practices across the US using a standardized electronic medical record system. Treatment-naïve eyes were included if they had a nAMD diagnosis, a first ranibizumab or aflibercept injection between July 2011 and July 2014, at least one record of switch treatment and a BCVA reading at Month 12 (M12) post-switch. Eyes were excluded if they discontinued index treatment (>180 days with no treatment or BCVA reading) prior to receipt of switch treatment. The primary outcome was the mean (±standard deviation [SD]) change in BCVA from switch to M12. Treatments were compared using ANCOVA adjusted for BCVA at switch and study drug. Mean BCVA change prior to switch was also assessed. A non-inferiority margin of 5 letters was applied both for baseline to switch and for switch to M12. Eye was the unit of analysis.

Results : 269 ranibizumab eyes (switching to aflibercept) and 83 aflibercept eyes (switching to ranibizumab) were evaluated. Aflibercept patients were slightly older (%patients >80 years-old: ranibizumab=54.7%; aflibercept=69.4%) and mean (±SD) baseline BCVA was similar [ranibizumab=58.9(±20.4); aflibercept=59.1(±19.7), p=0.96]. Pre-switch, eyes treated with ranibizumab had a higher BCVA gain before switch than eyes treated with aflibercept (+1.45(±1.0) vs. -3.6(±1.7), 95% CI -8.5; -1.6, p<0.05). Mean change in BCVA from switch to M12 was +0.2(±19.2) and -1.6(±13.4) for eyes switched to ranibizumab and aflibercept respectively (non-inferior, p=0.62). No statistical difference in mean BCVA change from switch to M12 was observed between treatments in eyes with <69 letters [ranibizumab=+0.5(±20.4) vs. aflibercept=-1.5(±14.3), p=0.71] and ≥69 letters [ranibizumab=-0.3(±17.5) vs. aflibercept=-1.7(±12.2), p=0.92] at baseline.

Conclusions : From baseline to the switch, statistical non-inferiority could not be concluded as the lower boundary of the confidence interval crossed the negative of the non-inferiority margin. Both aflibercept and ranibizumab provided a comparable change in BCVA at 12 months post-switch.

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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