Optimizing Strategies for Bevacizumab Injections in ARMD: A Randomized Controlled Trial using 4, 6 and 8 Weekly Injections

摘要

Purpose: : This RCT studies the influence of frequency of administration of Bevacizumab injections on functional and anatomical outcomes in patients with ARMD. Methods: : Ongoing prospective randomized controlled study. Patients (n=191) were allocated to one of three groups: 4 weekly (n=63), 6 weekly (n=63) or 8 weekly (n=65) injections with 1,25/0,05cc Bevacizumab for 1 year. Visual acuity, and changes in OCT were analysed. Results: : At this point inclusion is completed, study in progress. 184 patients reached the 3 months, 175 the 6 months, 152 the 9 months and 134 the 12 months follow-up time point.At 3, 6, 9 and 12 months were no significant differences in gained ETDRS letters: p=0,31, p=0,68, p=0,56 and p=0,14 respectively. At 12 month ETDRS letters gained: 2,4?±13,9 in the 4 weekly group, 1,4?±11,5 in the 6 weekly and 5,9?±8,7 in the 8 weekly injection group. No significant differences in reduction of OCT minimal foveal thickness were observed at 3, 6, 9 and even 12 moths time point: p=0,17, p=0,48, p=0,13 and p=0,46 respectively.At 12 months a reduction of 107,8?±90 um, 83,0?±86,6 um and 97,2?±102um in the 4 weekly, 6 weekly and 8 weekly group respectively was found. Conclusions: : In this ongoing study at 3, 6, 9 an 12 months follow-up point no superiority between 4-weekly, 6-weekly or 8-weekly Bevacizumab injections for ARMD could be observed. Clinical Trial: : ROI, 2007-06.