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评估在 12 周的时间内接受玻璃体内阿柏西普(艾力雅)治疗的新生血管性年龄相关性黄斑变性患者的光谱域光相干断层扫描的早期变化:一项多中心法国研究(START)。

ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START).

机构信息

Service D'Ophtalmologie, Hôpital Pellegrin, CHU de Bordeaux, Bordeaux, France.

Université de Bordeaux, Inserm, Bordeaux Population Health Research Center, Leha team, UMR 1219, Bordeaux, France.

出版信息

Retina. 2021 Mar 1;41(3):588-594. doi: 10.1097/IAE.0000000000002910.

DOI:10.1097/IAE.0000000000002910
PMID:33600134
Abstract

PURPOSE

To assess early changes in spectral-domain optical coherence tomography during the loading phase with intravitreal aflibercept therapy in patients with neovascular age-related macular degeneration.

METHODS

In this prospective, open-label, single-arm, multicenter study, patients with neovascular age-related macular degeneration, who were antivascular endothelial growth factor treatment-naïve, received three monthly initial doses of intravitreal aflibercept 2 mg. The primary outcome was the proportion of patients with dry spectral-domain optical coherence tomography at 12 weeks, defined as an absence of intraretinal edema, intraretinal cysts, subretinal fluid, and subretinal pigment epithelium fluid.

RESULTS

Fifty eyes of 50 patients were investigated. At 12 weeks, 34.0% (17/50) had dry spectral-domain optical coherence tomography. Marked reductions were observed for all other spectral-domain optical coherence tomography parameters. The mean macular central thickness fell significantly from 463.2 ± 184.3 µm at baseline to 288.9 ± 76.8 µm at Week 12 (P < 0.0001). The mean best-corrected visual acuity also improved significantly from 61.0 ± 16.0 letters at baseline to 66.6 ± 19.0 letters at Week 12 (P = 0.0006).

CONCLUSION

The anatomic and functional outcomes improved over the 12-week study period. All outcome variables peaked after the third aflibercept injection, confirming the benefit of three initial doses.

摘要

目的

评估新生血管性年龄相关性黄斑变性患者玻璃体腔内注射阿柏西普治疗加载期的频域光学相干断层扫描早期变化。

方法

本前瞻性、开放标签、单臂、多中心研究纳入了初治抗血管内皮生长因子治疗的新生血管性年龄相关性黄斑变性患者,患者接受玻璃体腔内注射阿柏西普 2mg,每月 1 次,共 3 次。主要结局是在 12 周时干性频域光学相干断层扫描的患者比例,定义为无视网膜内水肿、视网膜内囊泡、视网膜下液和视网膜色素上皮下液。

结果

共纳入 50 例 50 只眼。在 12 周时,34.0%(17/50)患者为干性频域光学相干断层扫描。所有其他频域光学相干断层扫描参数均有明显下降。黄斑中心视网膜厚度从基线时的 463.2±184.3μm显著下降至 12 周时的 288.9±76.8μm(P<0.0001)。最佳矫正视力也显著提高,从基线时的 61.0±16.0 个字母提高至 12 周时的 66.6±19.0 个字母(P=0.0006)。

结论

在 12 周的研究期间,解剖和功能结局均有所改善。所有结局变量在第三次阿柏西普注射后达到峰值,证实了三次初始剂量的获益。

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ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START).评估在 12 周的时间内接受玻璃体内阿柏西普(艾力雅)治疗的新生血管性年龄相关性黄斑变性患者的光谱域光相干断层扫描的早期变化:一项多中心法国研究(START)。
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