Abstract
Purpose: :
The purpose of this research is to determine recurrence time of Choroidal Neovascularization (CNV) in Age-Related Macular degeneration (ARMD) after patients have been treated with Bevacizumab for 1 year with a fixed treatment schedule.
Methods: :
180 patients with ARMD were treated with Bevacizumab for 1 year. At inclusion all patient were randomized into 3 treatment groups. Group 1 was treated with Bevacizumab every 4 weeks (n=60), Group 2 treated with Bevacizumab every 6 weeks (n=60) and Group 3 was treated with Bevacizumab every 8 weeks (n=60). At the end of 1 year treatment the CNV activity was determined in all patients with a FAG, ICG, OCT and Fundoscopy. Bevacizumab treatment was resumed if necessary at that point or at any stage during regular follow-up afterwards. Recurrence of CNV was defined as a drop in vision (5 letters or more), new fluid on OCT, a 50µm increase in Central Foveal Thickness in OCT and/or new blood/fluid found by funduscopy. No significant differences between groups existed for visual acuity or lesion size at the 1 year point, prior to the follow-up stage.
Results: :
121 patients have finished their initial 1 year treatment (Group 1: N=38, Group 2: N=39 and Group 3: N=44). In 91 patients a recurrence of CNV was reported. Retreatment occurred at 5,04±0.84 months (mean±SEM) in group 1, at 4,82±0.89 months (mean±SEM) in group 2 and at 6.71±0.95 months in group 3. Log-Rank test on the survival data showed no significant difference (Sig. =0.24) in recurrence time for the 3 different treatment groups.
Conclusions: :
These preliminary results with 121 of 180 patients, initially treated with a fixed schedule of Bevacizumab injections, suggest that the time to recurrence of CNV is not dependent on the frequency of previous injections. Follow-up will be extended to study the long term recurrence rate in all 180 patients.
Clinical Trial: :
http://www.trialregister.nl/trialreg/index.asp NTR1174
Keywords: age-related macular degeneration