April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Randomised controlled trial over 92 weeks using bevacizumab for the treatment of neovascular age-related macular degeneration comparing a treatment regime with 12 weekly regular injections to one with injections on an as-needed basis.
Author Affiliations & Notes
  • Paul N Bishop
    Centre for Hearing & Vision Research, University of Manchester, Manchester, United Kingdom
    Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
  • Stephen Roberts
    Centre for Biostatistics, University of Manchester, Manchester, United Kingdom
  • Tariq Aslam
    Centre for Hearing & Vision Research, University of Manchester, Manchester, United Kingdom
    Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
  • Stephen Charles
    Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
  • Paulo E Stanga
    Centre for Hearing & Vision Research, University of Manchester, Manchester, United Kingdom
    Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
  • Jeremy Parkes
    Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
  • Sajjad Mahmood
    Centre for Hearing & Vision Research, University of Manchester, Manchester, United Kingdom
    Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
  • Footnotes
    Commercial Relationships Paul Bishop, None; Stephen Roberts, None; Tariq Aslam, Bayer (F), Novartis (F); Stephen Charles, None; Paulo Stanga, Bayer (C), Bayer (R), Novartis (C), Novartis (R); Jeremy Parkes, None; Sajjad Mahmood, Bayer (F), Bayer (R), Novartis (F), Novartis (R)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 1646. doi:
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      Paul N Bishop, Stephen Roberts, Tariq Aslam, Stephen Charles, Paulo E Stanga, Jeremy Parkes, Sajjad Mahmood; Randomised controlled trial over 92 weeks using bevacizumab for the treatment of neovascular age-related macular degeneration comparing a treatment regime with 12 weekly regular injections to one with injections on an as-needed basis.. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1646.

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

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Abstract

Purpose: To evaluate in a single centre, randomised clinical trial two different treatment regimens using intravitreal bevacizumab.

Methods: In this non-inferiority design RCT, 331 patients were followed up for 92 weeks after being randomised into one of two groups. All participants received 3 monthly loading doses of bevacizumab and subsequently had pre-planned visits every 12 weeks. At these visits patients in one arm received a regular injection of bevacizumab whilst patients in the other were treated on an as-needed basis. Both groups had additional interim evaluations and treatments 6 weeks after the last visit if they were deemed to have active disease, based upon change in BCVA, OCT and fluorescein angiography. The primary outcome measure was BCVA at 92 weeks, measured by masked investigators, with a pre-specified non-inferiority margin of 5 letters.

Results: At 92 weeks the regular treatment arm showed superiority to the as-needed treatment arm (p = 0.001) with the regular treatment arm gaining a mean vision of 5.7 letters and the as-needed treatment arm gaining 0.1 letters. There was no significant difference in BCVA between arms at 20 weeks (p = 0.165), but at 44 weeks there was a signifcant difference (p=0.001). The regular treatment arm showed significantly improved outcomes with respect to 5, 10 and 15 letter changes in vision from baseline compared to the as-needed treatment arm at 92 weeks. A full analysis of adverse events will be reported.

Conclusions: Regular treatment with 3 monthly injections of bevacizumab with interim treatments as required produced a stable improvement in BCVA from baseline over 92 weks and was superior to the as-needed treatment regime used in this study.

Keywords: 412 age-related macular degeneration • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 453 choroid: neovascularization  
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