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Peter Kertes, Tom Sheidow, Geoff Williams, Mark Greve, Ivan John Galic, Emmanouil Rampakakis, Bernard Bourgault, Anne-Sophie Courseau; Canadian Treat and Extend Analysis Trial with Ranibizumab in Patients with Neovascular AMD: Interim Analysis of the CANTREAT Study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):538.
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© ARVO (1962-2015); The Authors (2016-present)
The concept of individualized pro re nata regimens based on BCVA stability over 3 months has been demonstrated. Given that recurrence of disease instability leads to vision loss, the role of OCT in evaluating nAMD activity for decision making needs to be assessed. Furthermore, to date, only retrospective evidence exists. The aim of this 24-month prospective, randomized (1:1), open-label, multicenter, post-authorization study is to assess the non-inferiority of an OCT-based treat-and-extend (T&E) regimen with ranibizumab compared to monthly dosing (Monthly) in treatment-naive patients with neovascular AMD.
A 12-month interim analysis assessing baseline characteristics, visual acuity, and injection frequency was performed. Summary statistics including the mean and standard deviation for continuous variables and counts and percentages for categorical variables were produced.
As of November 4th, 2015, 441 patients (NT&E=223; NMonthly=218) were recruited; 215 patients (NT&E=109; NMonthly=106) had 12-month follow-up data. Mean (SD) age was 79.6 (7.6) and 59.9% were females, with no differences between groups. In these patients with at least 12 months of follow-up data, mean (SD) baseline BCVA was 57.3 (14.5) and 59.5 (13.5) [total study cohort: 57.7 (14.4) and 58.4 (13.5), respectively] for the T&E and Monthly groups, respectively. At month-12, after an average of 9.7 (T&E) and 11.8 (Monthly) injections, mean (SD) BCVA improvement was 8.5 (13.3) and 6.0 (11.8) letters, respectively.
The results of this interim analysis suggest that comparable or greater improvement in BCVA may be achieved in a real-world setting with fewer injections required with T&E using an OCT-based treatment algorithm compared to a monthly dosing regimen.
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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