背景:本研究的目的是研究在现实条件下,抗血管内皮生长因子(抗VEGF)治疗新生血管性年龄相关性黄斑变性(nAMD)患者后持续疾病活动的预测因素及其长期影响。
方法:PROOF研究的回顾性数据分析,在韩国对nAMD患者进行的多中心真实世界回顾性图表审查包括首次接受抗VEGF治疗的nAMD患者(雷珠单抗,贝伐单抗,或aflibercept)在2017年1月至2019年3月期间进行。所有600名患者(队列1)的最低随访时间为12个月,其中453名患者(队列2)从基线开始随访24个月。
结果:抗VEGF治疗后12个月,58.10%(95%置信区间[CI]:54.09,62.12)的患者和在第24个月时,66.02%的患者持续存在视网膜液。在12个月和24个月,持续疾病活动的预测因素是纤维血管色素上皮脱离(PED)(P=0.0494)和负荷阶段后第3个月的视网膜液(P=0.0082)。视力的平均变化分别为+6.2、+10.1和+13.3个字母,中心子场厚度为-79.1µm,-96.3µm,从基线开始12个月时-134.4µm,在贝伐单抗中,aflibercept,和雷珠单抗组,分别。
结论:负荷期后视网膜液和纤维血管PED的存在是抗VEGF治疗至少1年后持续性疾病活动的预测因子。
BACKGROUND: The aim of this study was to investigate the predictive factors for persistent disease activity following anti-vascular endothelial growth factors (anti-VEGF) and their long-term effects in patients to be treated for neovascular age-related macular degeneration (nAMD) under real-world conditions.
METHODS: Retrospective data analysis of the PROOF study, a multi-center real-world retrospective chart review conducted across Korea in patients with nAMD included treatment-naive patients with nAMD who received first anti-VEGF (
ranibizumab, bevacizumab, or aflibercept) between January 2017 and March 2019 was performed. All 600 patients (cohort 1) had a minimum follow-up of 12 months of which 453 patients (cohort 2) were followed-up for 24 months from baseline.
RESULTS: At month 12 after anti-VEGF therapy, 58.10% (95% confidence interval [CI]: 54.09, 62.12) of patients and at month 24, 66.02% of patients continued to have persistent retinal fluid. At both months 12 and 24, predictive factors for persistent disease activity were fibrovascular pigment epithelial detachments (PED) (P = 0.0494) and retinal fluid at month 3 after loading phase (P = 0.0082). The mean changes in visual acuity were + 6.2, + 10.1, and + 13.3 letters and in the central subfield thickness were - 79.1 µm, - 96.3 µm, and - 134.4 µm at 12 months from baseline, in the bevacizumab, aflibercept, and
ranibizumab groups, respectively.
CONCLUSIONS: The presence of retinal fluid after loading phase and fibrovascular PED were predictors of persistent disease activity after at least 1 year of anti-VEGF treatment.