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抗血管内皮生长因子治疗新生血管性年龄相关性黄斑变性的五年结果:年龄相关性黄斑变性治疗试验比较

Five-Year Outcomes with Anti-Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration: The Comparison of Age-Related Macular Degeneration Treatments Trials.

作者信息

Maguire Maureen G, Martin Daniel F, Ying Gui-Shuang, Jaffe Glenn J, Daniel Ebenezer, Grunwald Juan E, Toth Cynthia A, Ferris Frederick L, Fine Stuart L

机构信息

Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.

Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.

出版信息

Ophthalmology. 2016 Aug;123(8):1751-1761. doi: 10.1016/j.ophtha.2016.03.045. Epub 2016 May 2.

Abstract

PURPOSE

To describe outcomes 5 years after initiating treatment with bevacizumab or ranibizumab for neovascular age-related macular degeneration (AMD).

DESIGN

Cohort study.

PARTICIPANTS

Patients enrolled in the Comparison of AMD Treatments Trials.

METHODS

Patients were assigned randomly to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. After 2 years, patients were released from the clinical trial protocol. At 5 years, patients were recalled for examination.

MAIN OUTCOME MEASURES

Visual acuity (VA) and morphologic retinal features.

RESULTS

Visual acuity was obtained for 647 of 914 (71%) living patients with average follow-up of 5.5 years. The mean number of examinations for AMD care after the clinical trial ended was 25.3, and the mean number of treatments was 15.4. Most patients (60%) were treated 1 time or more with a drug other than their assigned drug. At the 5-year visit, 50% of eyes had VA of 20/40 or better and 20% had VA of 20/200 or worse. Mean change in VA was -3 letters from baseline and -11 letters from 2 years. Among 467 eyes with fluorescein angiography, mean total lesion area was 12.9 mm(2), a mean of 4.8 mm(2) larger than at 2 years. Geographic atrophy was present in 213 of 515 (41%) gradable eyes and was subfoveal in 85 eyes (17%). Among 555 eyes with spectral-domain optical coherence tomography, 83% had fluid (61% intraretinal, 38% subretinal, and 36% sub-retinal pigment epithelium). Mean foveal total thickness was 278 μm, a decrease of 182 μm from baseline and 20 μm from 2 years. The retina was abnormally thin (<120 μm) in 36% of eyes. Between 2 and 5 years, the group originally assigned to ranibizumab for 2 years lost more VA than the bevacizumab group (-4 letters; P = 0.008). Otherwise, there were no statistically significant differences in VA or morphologic outcomes between drug or regimen groups.

CONCLUSIONS

Vision gains during the first 2 years were not maintained at 5 years. However, 50% of eyes had VA of 20/40 or better, confirming anti-vascular endothelial growth factor therapy as a major long-term therapeutic advance for neovascular AMD.

摘要

目的

描述使用贝伐单抗或雷珠单抗治疗新生血管性年龄相关性黄斑变性(AMD)5年后的治疗结果。

设计

队列研究。

参与者

纳入AMD治疗试验比较研究的患者。

方法

患者被随机分配至雷珠单抗或贝伐单抗,并采用3种给药方案中的1种。2年后,患者退出临床试验方案。在5年时,召回患者进行检查。

主要观察指标

视力(VA)和视网膜形态特征。

结果

914例存活患者中有647例(71%)获得了视力数据,平均随访时间为5.5年。临床试验结束后,AMD护理的平均检查次数为25.³次,平均治疗次数为15.⁴次。大多数患者(60%)接受了1次或更多次除分配药物以外的其他药物治疗。在5年随访时,50%的患眼视力为20/40或更好,20%的患眼视力为20/200或更差。视力的平均变化较基线下降了3行,较2年时下降了11行。在467例接受荧光素血管造影的患眼中,平均总病变面积为12.⁹mm²,比2年时平均大4.⁸mm²。515例可分级的患眼中有213例(41%)出现地图样萎缩,其中85例(17%)为黄斑中心凹下萎缩。在555例接受光谱域光学相干断层扫描的患眼中,83%有液体积聚(61%为视网膜内积液,38%为视网膜下积液,36%为视网膜色素上皮下积液)。黄斑中心凹平均总厚度为27⁸μm,较基线下降了18²μm,较2年时下降了2⁰μm。36%的患眼视网膜异常变薄(<12⁰μm)。在2年至5年期间,最初分配接受2年雷珠单抗治疗的组比贝伐单抗组视力下降更多(下降4行;P = 0.⁰⁰⁸)。除此之外,药物或给药方案组之间在视力或形态学结果方面没有统计学上的显著差异。

结论

最初2年获得的视力改善在5年时未得到维持,但50%的患眼视力为20/40或更好,这证实了抗血管内皮生长因子治疗是新生血管性AMD的一项重大长期治疗进展。

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