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阿柏西普治疗既往治疗过的与视网膜中央静脉阻塞相关的黄斑水肿:NEWTON研究的1年结果

Aflibercept for Previously Treated Macular Edema Associated with Central Retinal Vein Occlusions: 1-Year Results of the NEWTON Study.

作者信息

Khurana Rahul N, Chang Louis K, Bansal Alok S, Palmer James D, Wu Chengqing, Wieland Mark R

机构信息

Northern California Retina Vitreous Associates, Mountain View, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.

Northern California Retina Vitreous Associates, Mountain View, California.

出版信息

Ophthalmol Retina. 2018 Feb;2(2):128-133. doi: 10.1016/j.oret.2017.05.017. Epub 2017 Oct 12.

Abstract

PURPOSE

To determine whether aflibercept (Eylea; Regeneron Pharmaceuticals, Tarrytown, NY) can extend the macular edema-free interval in patients with nonischemic central retinal vein occlusions (CRVOs) previously treated with ranibizumab (Lucentis; Genentech, South San Francisco, CA) or bevacizumab (Avastin; Genentech, South San Francisco, CA).

DESIGN

Prospective, single-arm, interventional study.

PARTICIPANTS

Twenty patients with chronic nonischemic CRVOs.

METHODS

Patients with nonischemic CRVOs previously treated with ranibizumab or bevacizumab were switched to aflibercept. The inclusion criteria included treatment for ≥6 months with ≥3 initial loading doses and evidence of recurrence of edema when treatment with either ranibizumab or bevacizumab extended beyond 4 weeks. Intravitreal aflibercept was administered with a treat-and-extend dosing regimen. Injection frequencies were extended 2 weeks if there were no signs of disease activity on OCT or change in visual acuity.

MAIN OUTCOME MEASURES

Macular edema-free interval at week 52.

RESULTS

Twenty patients had an average duration of a CRVO for 22 months (range, 7-90 months) and averaged an anti-vascular endothelial growth factor (anti-VEGF) treatment every 42 days (range, 28-60 days). These patients received a mean of 15 treatments (range, 5-47 treatments) of ranibizumab or bevacizumab for macular edema secondary to nonischemic CRVO. Among the 17 patients who completed 1 year of follow-up, 94% had a greater macular edema-free interval with aflibercept treatment. The macular edema-free interval increased from 5.4 weeks to 9.1 weeks when treatment was switched to aflibercept (P = 0.000003). There was an average increase of 26 days (range, 0-63 days) in the macular edema free interval with aflibercept. There was an improvement in vision (+6 Early Treatment Diabetic Retinopathy Study letters, P = 0.02) and decreased retinal thickness (152 μm, P = 0.0002) with aflibercept treatment.

CONCLUSIONS

In patients previously treated with ranibizumab or bevacizumab for macular edema due to nonischemic CRVO, aflibercept increased the macular edema free interval. This may help minimize the treatment burden in patients with recurrent macular edema secondary to nonischemic CRVO.

摘要

目的

确定阿柏西普(Eylea;再生元制药公司,纽约州塔里敦)是否能延长先前接受过雷珠单抗(Lucentis;基因泰克公司,加利福尼亚州南旧金山)或贝伐单抗(阿瓦斯汀;基因泰克公司,加利福尼亚州南旧金山)治疗的非缺血性中央视网膜静脉阻塞(CRVO)患者的无黄斑水肿间隔时间。

设计

前瞻性、单臂、干预性研究。

参与者

20例慢性非缺血性CRVO患者。

方法

先前接受过雷珠单抗或贝伐单抗治疗的非缺血性CRVO患者改用阿柏西普。纳入标准包括接受≥6个月治疗且初始负荷剂量≥3次,以及当雷珠单抗或贝伐单抗治疗超过4周时出现水肿复发的证据。玻璃体内注射阿柏西普采用治疗并延长给药方案。如果光学相干断层扫描(OCT)上没有疾病活动迹象或视力没有变化,则注射频率延长2周。

主要观察指标

第52周时的无黄斑水肿间隔时间。

结果

20例患者CRVO的平均病程为22个月(范围7 - 90个月),平均每42天(范围28 - 60天)接受一次抗血管内皮生长因子(抗VEGF)治疗。这些患者因非缺血性CRVO继发黄斑水肿平均接受了15次(范围5 - 47次)雷珠单抗或贝伐单抗治疗。在完成1年随访的17例患者中,94%接受阿柏西普治疗后无黄斑水肿间隔时间更长。改用阿柏西普治疗后,无黄斑水肿间隔时间从5.4周增加到9.1周(P = 0.000003)。使用阿柏西普后,无黄斑水肿间隔时间平均增加26天(范围0 - 63天)。阿柏西普治疗后视力有改善(提高6个早期糖尿病性视网膜病变研究字母,P = 0.02),视网膜厚度降低(152μm,P = 0.0002)。

结论

在先前因非缺血性CRVO继发黄斑水肿而接受雷珠单抗或贝伐单抗治疗的患者中,阿柏西普延长了无黄斑水肿间隔时间。这可能有助于减轻非缺血性CRVO继发复发性黄斑水肿患者的治疗负担。

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