Purchase this article with an account.
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.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To evaluate in a single centre, randomised clinical trial two different treatment regimens using intravitreal bevacizumab.
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.
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.
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.
This PDF is available to Subscribers Only