病理性近视脉络膜新生血管:玻璃体内雷珠单抗与贝伐单抗的随机对照试验。

Choroidal neovascularization in pathologic myopia: intravitreal ranibizumab versus bevacizumab--a randomized controlled trial.

机构信息

Department of Ophthalmology, University of Rome La Sapienza, Rome, Italy.

出版信息

Am J Ophthalmol. 2010 Mar;149(3):458-64.e1. doi: 10.1016/j.ajo.2009.10.010.

Abstract

PURPOSE

To compare the short-term efficacy and safety of intravitreal ranibizumab versus bevacizumab in treating myopic choroidal neovascularization (CNV).

DESIGN

Prospective, comparative, randomized, interventional study.

METHODS

Thirty-two eyes from 32 patients with myopic CNV were consecutively enrolled and randomly treated, in a 1:1 ratio, with intravitreal ranibizumab (0.5 mg) or bevacizumab (1.25 mg) as needed, after the first injection. ETDRS best-corrected visual acuity (BCVA), foveal center thickness (FCT) on optical coherence tomography (OCT), and fluorescein angiographic findings were examined before and after treatment. Patients were followed up for 6 months.

RESULTS

No statistically significant difference in the BCVA improvement, as well as in the FCT reduction, was found between groups during follow-up (P value at 1, 3, 6 months > .05). Complete resolution of fluorescein leakage was observed in all 16 bevacizumab-treated eyes and in 15 out of 16 (93.7%) ranibizumab-treated eyes. No ocular or systemic adverse effects from treatment were encountered.

CONCLUSION

This randomized clinical study cannot determine a statistically significant difference in anti-VEGF treatment effect between ranibizumab and bevacizumab for the treatment of CNV secondary to pathologic myopia. A larger study is required to determine the relative efficacy and duration of action of these drugs.

摘要

目的

比较玻璃体内雷珠单抗与贝伐单抗治疗近视性脉络膜新生血管(CNV)的短期疗效和安全性。

设计

前瞻性、对比、随机、干预性研究。

方法

连续纳入 32 例(32 只眼)近视性 CNV 患者,按 1:1 比例随机接受玻璃体内雷珠单抗(0.5mg)或贝伐单抗(1.25mg)按需治疗,首次注射后。采用 ETDRS 最佳矫正视力(BCVA)、光学相干断层扫描(OCT)中心凹厚度(FCT)和荧光素血管造影检查评估治疗前后的结果。患者随访 6 个月。

结果

在随访期间,两组的 BCVA 改善和 FCT 降低均无统计学差异(P 值在 1、3、6 个月时均>0.05)。所有 16 只贝伐单抗治疗眼和 16 只雷珠单抗治疗眼中的 15 只(93.7%)荧光素渗漏完全消退。未出现与治疗相关的眼部或全身不良反应。

结论

本随机临床研究不能确定雷珠单抗与贝伐单抗治疗病理性近视继发 CNV 的抗 VEGF 治疗效果存在统计学差异。需要更大的研究来确定这些药物的相对疗效和作用持续时间。

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