Rotterdam Eye Hospital, Rotterdam, the Netherlands.
Rotterdam Ophthalmic Institute, Rotterdam, the Netherlands.
Acta Ophthalmol. 2019 Feb;97(1):107-112. doi: 10.1111/aos.13774. Epub 2018 Oct 27.
Intravitreal anti-vascular endothelial growth factor (VEGF) injections are an effective treatment for neovascular age-related macular degeneration (nARMD). Bevacizumab appears to be a cost-effective off-label anti-VEGF alternative to ranibizumab, but an optimal injection schedule has not yet been determined. In this study, we investigate whether on-demand bevacizumab treatment every 8 weeks is non-inferior to on-demand bevacizumab every 4 weeks in treating nARMD.
A total of 120 nARMD patients were randomly assigned to an on-demand regimen of intravitreal bevacizumab (IVB) every 4 (n = 60) or 8 weeks (n = 60). The primary outcome was visual acuity (VA) change after 1 year of treatment.
Visual acuity (VA) improved between baseline and 1 year in both treatment groups. The mean change in the VA score at 1 year was not significantly different between bevacizumab administration on-demand every 4 weeks [5.6 ± 10.2 Early Treatment Diabetic Retinopathy Study (ETDRS) letter] or 8 weeks (4.6 ± 12.0 ETDRS letters). A reduction in the central retinal thickness was observed in both groups. At 1 year, the mean decrease in central foveal thickness ranged from 61 ± 90 μm in the 4-week group to 91 ± 83 μm in the 8-week group (p = 0.07). The mean number of IVB treatments during the study period was 8.7 ± 2.3 in the 4-week group and 5.9 ± 1.0 in the 8-week group.
At 1 year, bevacizumab administration on-demand every 8 weeks was non-inferior to administration every 4 weeks. The results strongly suggest that bevacizumab acts longer than 4 weeks in ARMD, reducing the burden of injections for patients.
玻璃体内抗血管内皮生长因子(VEGF)注射是治疗新生血管性年龄相关性黄斑变性(nAMD)的有效方法。贝伐单抗似乎是一种比雷珠单抗更具成本效益的非适应证抗 VEGF 药物,但尚未确定最佳注射方案。本研究旨在探讨按需每 8 周注射贝伐单抗是否不如按需每 4 周注射贝伐单抗治疗 nAMD。
共 120 名 nAMD 患者被随机分为按需玻璃体内注射贝伐单抗(IVB)每 4 周(n=60)或 8 周(n=60)组。主要结局是治疗 1 年后的视力(VA)变化。
两组患者的 VA 在基线和 1 年均有改善。1 年后 VA 评分的平均变化在贝伐单抗按需每 4 周(5.6±10.2 早期糖尿病视网膜病变研究(ETDRS)字母)或 8 周(4.6±12.0 ETDRS 字母)给药组之间无显著差异。两组的视网膜中央厚度均有下降。1 年后,中央凹视网膜厚度的平均下降范围为 4 周组的 61±90μm 至 8 周组的 91±83μm(p=0.07)。研究期间,4 周组的平均 IVB 治疗次数为 8.7±2.3,8 周组为 5.9±1.0。
在 1 年时,按需每 8 周注射贝伐单抗与每 4 周注射贝伐单抗等效。结果强烈表明贝伐单抗在 ARMD 中作用时间长于 4 周,减少了患者的注射负担。