PURPOSE: Several clinical trials have established the efficacy of ranibizumab therapy administered every 4 weeks to treat exudative age-related macular degeneration (ARMD). Bevacizumab appears to be a cost-effective alternative to ranibizumab, although an optimal injection schedule has not yet been determined. In this study, we set out to determine whether bevacizumab treatment in exudative ARMD every 6 or 8 weeks is non-inferior to bevacizumab treatment every 4 weeks. METHODS: A total of 191 patients with exudative ARMD were randomly assigned to a 1-year continuous regimen of intravitreal bevacizumab every 4 (n = 64), 6 (n = 63) or 8 weeks (n = 64). The primary outcome was visual acuity change after 1 year of treatment. RESULTS: In all three treatment groups, visual acuity improved between baseline and 1 year. There was no statistically significant difference in the mean change of visual acuity score at 1 year for bevacizumab administered every 4 (1.96 ± 13.70), 6 (1.60 ± 10.98) or 8 weeks (5.98 ± 8.88). Reduction in central retinal thickness was observed in all three study groups. At 1 year, the mean decrease in central foveal thickness ranged from 86 ± 97 μm in the every 6 weeks group to 109 ± 90 μm in the group every 8 weeks group (p = 0.30). CONCLUSION: At 1 year, bevacizumab administered every 6 or 8 weeks was not inferior to therapy administered every 4 weeks.
RCT Entities:
PURPOSE: Several clinical trials have established the efficacy of ranibizumab therapy administered every 4 weeks to treat exudative age-related macular degeneration (ARMD). Bevacizumab appears to be a cost-effective alternative to ranibizumab, although an optimal injection schedule has not yet been determined. In this study, we set out to determine whether bevacizumab treatment in exudative ARMD every 6 or 8 weeks is non-inferior to bevacizumab treatment every 4 weeks. METHODS: A total of 191 patients with exudative ARMD were randomly assigned to a 1-year continuous regimen of intravitreal bevacizumab every 4 (n = 64), 6 (n = 63) or 8 weeks (n = 64). The primary outcome was visual acuity change after 1 year of treatment. RESULTS: In all three treatment groups, visual acuity improved between baseline and 1 year. There was no statistically significant difference in the mean change of visual acuity score at 1 year for bevacizumab administered every 4 (1.96 ± 13.70), 6 (1.60 ± 10.98) or 8 weeks (5.98 ± 8.88). Reduction in central retinal thickness was observed in all three study groups. At 1 year, the mean decrease in central foveal thickness ranged from 86 ± 97 μm in the every 6 weeks group to 109 ± 90 μm in the group every 8 weeks group (p = 0.30). CONCLUSION: At 1 year, bevacizumab administered every 6 or 8 weeks was not inferior to therapy administered every 4 weeks.
Authors: Yeoun-Hee Kim; Jae-Chang Jung; Sang Il Gum; Su-Bin Park; Jin Yeul Ma; Yong Il Kim; Kyoo Won Lee; Young Jeung Park Journal: PLoS One Date: 2017-01-09 Impact factor: 3.240
Authors: Martijn S Visser; Sankha Amarakoon; Tom Missotten; Reinier Timman; Jan J V Busschbach Journal: Qual Life Res Date: 2020-07-14 Impact factor: 4.147