雷珠单抗治疗视网膜静脉阻塞继发黄斑水肿的视力相关功能改善：BRAVO 和 CRUISE 试验的结果。
Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials.
机构信息
Doheny Eye Institute, University of Southern California, Los Angeles, California, USA.
出版信息
Ophthalmology. 2012 Oct;119(10):2108-18. doi: 10.1016/j.ophtha.2012.05.017. Epub 2012 Jul 18.
PURPOSE
To examine the impact of intravitreal ranibizumab on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) through 6 months in patients with macular edema (ME) secondary to branch or central retinal vein occlusion (RVO).
DESIGN
Two multicenter, double-masked trials, which enrolled participants with ME secondary to branch or central RVO: the RanibizumaB for the Treatment of Macular Edema following BRAnch Retinal Vein Occlusion: Evaluation of Efficacy and Safety (BRAVO) trial or the Central Retinal Vein OcclUsIon Study: Evaluation of Efficacy and Safety (CRUISE) trial.
PARTICIPANTS
Three hundred ninety-seven BRAVO and 392 CRUISE patients.
METHODS
Patients were randomized 1:1:1 to monthly sham, 0.3-mg, or 0.5-mg injections of ranibizumab for 6 months.
MAIN OUTCOME MEASURES
Although visual acuity was the main outcome measure for the trials, mean change from baseline in NEI VFQ-25 scores at month 6 was a secondary outcome measure.
RESULTS
In BRAVO, among the 132, 134, and 131 patients randomized, respectively, to sham, 0.3 mg ranibizumab, or 0.5 mg ranibizumab, the study eye was the worse-seeing eye in 121 (91.7%), 118 (88.1%), and 125 (95.4%) patients and 123 (93.2%), 128 (95.5%), and 125 (95.4%), respectively, had a 6-month follow-up visit. In CRUISE, among the 130, 132, and 130 patients randomized, respectively, to sham, 0.3 mg ranibizumab, and 0.5 mg ranibizumab, the study eye was the worse-seeing eye in 117 (90.0%), 123 (93.2%), and 120 (92.3%) patients and 115 (88.5%), 129 (97.7%), and 119 (91.5%), respectively, had a 6-month follow-up visit. In both trials, patients treated with ranibizumab reported greater mean improvements in visual function, with substantial differences observed as early as month 1, including the NEI VFQ-25 composite score and near and distance activities subscales, compared with sham patients. P values for comparisons with sham for the composite score and these 2 subscales were <0.05.
CONCLUSIONS
These results from the BRAVO and CRUISE trials indicate that patients with ME from RVOs treated with monthly ranibizumab report greater improvements in vision-related function compared with sham-treated patients through 6 months, even when a majority of patients present with RVOs in the worse-seeing eye.
目的
通过 6 个月的随访，使用 25 项国家眼科研究所视觉功能问卷（NEI VFQ-25）评估分支或中央视网膜静脉阻塞（RVO）继发黄斑水肿（ME）患者接受玻璃体内雷珠单抗治疗后患者报告的视觉功能。
设计
两项多中心、双盲试验，纳入了分支或中央 RVO 继发 ME 的患者：分支视网膜静脉阻塞治疗中雷珠单抗的疗效和安全性评估（BRAVO）试验或中央视网膜静脉阻塞研究：评估疗效和安全性（CRUISE）试验。
参与者
BRAVO 试验有 397 例患者，CRUISE 试验有 392 例患者。
方法
患者以 1:1:1 的比例随机接受每月 sham 治疗、0.3mg 雷珠单抗或 0.5mg 雷珠单抗治疗，持续 6 个月。
主要结局指标
尽管视力是试验的主要结局指标，但 6 个月时 NEI VFQ-25 评分的平均变化是次要结局指标。
结果
在 BRAVO 试验中，分别有 132、134 和 131 例患者随机接受 sham 治疗、0.3mg 雷珠单抗或 0.5mg 雷珠单抗治疗，研究眼为较差眼的患者分别有 121 例（91.7%）、118 例（88.1%）和 125 例（95.4%），分别有 123 例（93.2%）、128 例（95.5%）和 125 例（95.4%）接受了 6 个月的随访。在 CRUISE 试验中，分别有 130、132 和 130 例患者随机接受 sham 治疗、0.3mg 雷珠单抗和 0.5mg 雷珠单抗治疗，研究眼为较差眼的患者分别有 117 例（90.0%）、123 例（93.2%）和 120 例（92.3%），分别有 115 例（88.5%）、129 例（97.7%）和 119 例（91.5%）接受了 6 个月的随访。在两项试验中，与 sham 治疗组相比，接受雷珠单抗治疗的患者报告视觉功能有更大的平均改善，从第 1 个月就观察到明显的差异，包括 NEI VFQ-25 综合评分以及近距和远距活动子量表。与 sham 治疗相比，这些子量表的复合评分的 P 值均＜0.05。
结论
来自 BRAVO 和 CRUISE 试验的这些结果表明，接受每月雷珠单抗治疗的 RVO 继发 ME 患者报告的视力相关功能改善程度优于 sham 治疗组，持续至 6 个月，即使大多数患者的较差眼存在 RVO。
Zotero 插件