Session Title: Free Paper Session 14: AMD IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 17:00
Venue: Room 111
First Author: : P.Kertes CANADA
Co Author(s): : T. Sheidow G. Williams M. Greve I. Galic E. Rampakakis J. Gavalakis
There have been few large prospective randomized clinical studies which have assessed the efficacy of a treat-and-extend (T&E) regimen compared with monthly dosing for the treatment of neovascular age-related macular degeneration (AMD). The purpose of this interim analysis was to compare the effectiveness of ranibizumab using a T&E regimen to once-monthly (OM) dosing in treatment-naïve neovascular AMD patients.
The ongoing CANTREAT study is a 24-month prospective, randomized (1:1), open-label, multicentre, post-authorization study conducted in Canada.
In this interim analysis, baseline characteristics, visual acuity, and injection frequency were evaluated in patients enrolled as of November 10th, 2016. Effectiveness was assessed at 12 and 24 months. Summary statistics including the mean and standard deviation for continuous variables and counts and percentages for categorical variables were produced.
As of the November 2016 analysis cutoff date, a total of 580 patients (T&E=287; OM=293) were recruited; 404 patients (T&E=209; OM=195) and 201 patients (T&E=102; OM=99) had 12-month and 24-month follow-up, respectively. Mean (SD) age was 79.3 (7.9) years, 60.3% were females, 94.3% were Caucasian, and 22.5% had a family history of AMD. No significant between-group differences were observed. Mean (SD) baseline best corrected visual acuity (BCVA) was 58.7 (14.2) and 59.4 (13.5) for T&E and OM, respectively, and was comparable for both groups. At Month 12, after an average of 9.2 (T&E) and 11.8 (OM) injections, mean (SD) BCVA improvement was 8.0 (12.6) and 6.2 (12.6) letters, respectively. At Month 24, after an average of 18.2 (T&E) and 23.6 (OM) injections, mean (SD) BCVA improvement was comparable between groups with 6.5 (15.3) and 6.0 (13.0) letters, respectively.
The results of the current interim analysis show that comparable improvement in BCVA can be achieved in a real-world setting with fewer injections and fewer visits using a T&E compared to a monthly dosing regimen.