特发性脉络膜新生血管性年龄相关性黄斑变性中椭圆体带完整性、视网膜下高反射物质和视网膜色素上皮病的纵向评估。
Longitudinal Assessment of Ellipsoid Zone Integrity, Subretinal Hyperreflective Material, and Subretinal Pigment Epithelium Disease in Neovascular Age-Related Macular Degeneration.
机构信息
The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Center for Ocular Research and Evaluation, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Novartis Pharmaceuticals, East Hanover, New Jersey.
出版信息
Ophthalmol Retina. 2021 Dec;5(12):1204-1213. doi: 10.1016/j.oret.2021.02.012. Epub 2021 Feb 26.
PURPOSE
To assess longitudinally the effect of anti-vascular endothelial growth factor (VEGF) treatment on ellipsoid zone (EZ) integrity, subretinal hyperreflective material (SHRM), and the sub-retinal pigment epithelium (sub-RPE) compartment in eyes with neovascular age-related macular degeneration (nAMD).
DESIGN
Post hoc analysis of the OSPREY clinical trial, a prospective, double-masked, phase 2 study comparing brolucizumab 6 mg with aflibercept 2 mg over 56 weeks.
PARTICIPANTS
Participants with treatment-naïve nAMD at the initiation of the trial were included in the analysis.
METHODS
Eyes were evaluated with spectral-domain OCT at 4-week intervals in the OSPREY trial (n = 81). Spectral-domain OCT scans collected from each visit were segmented automatically using a proprietary, machine learning-enabled higher-order feature-extraction platform for retinal layer, SHRM, and sub-RPE boundary lines, which were evaluated and corrected as needed by masked trained graders. The current analysis focused only on patients evaluated with the Cirrus (Zeiss) platform (n = 28).
MAIN OUTCOME MEASURES
Outcome measures included change from baseline in EZ-RPE (i.e., photoreceptor outer segment) volume, EZ-RPE central subfield thickness (CST), total EZ attenuation, SHRM volume, SHRM CST, and total sub-RPE volume. The correlation between each of these measures and best-corrected visual acuity (BCVA) at each visit was evaluated.
RESULTS
EZ-RPE volume and EZ-RPE CST showed significant increases, and total EZ attenuation, SHRM volume, SHRM CST, and total sub-RPE volume showed significant decreases from baseline at each visit from weeks 4 through 56 (P < 0.05 at each visit). Ellipsoid zone integrity measures and SHRM volume correlated significantly with BCVA at most visits (P < 0.05). No significant correlation was found between total sub-RPE volume and BCVA.
CONCLUSIONS
EZ integrity, SHRM, and sub-RPE disease features in eyes with nAMD showed improvement as early as week 4 of anti-VEGF treatment. EZ integrity measures and SHRM volume were predictors of visual acuity over the first year of treatment.
目的
评估抗血管内皮生长因子（VEGF）治疗对新生血管性年龄相关性黄斑变性（nAMD）患者椭圆体带（EZ）完整性、视网膜下高反射物质（SHRM）和视网膜下色素上皮（sub-RPE）层的纵向影响。
设计
OSPREY 临床试验的事后分析，这是一项比较 brolucizumab 6 mg 与 aflibercept 2 mg 治疗 56 周的前瞻性、双盲、2 期研究。
参与者
在试验开始时患有未经治疗的 nAMD 的参与者被纳入分析。
方法
在 OSPREY 试验中，每 4 周进行一次光谱域 OCT 评估（n=81）。使用专有的、基于机器学习的高阶特征提取平台自动对从每次就诊收集的光谱域 OCT 扫描进行分段，该平台可对视网膜层、SHRM 和 sub-RPE 边界线进行评估和校正，由经过培训的盲 graded 分级员进行校正。当前分析仅关注使用 Cirrus（蔡司）平台评估的患者（n=28）。
主要观察指标
包括从基线开始 EZ-RPE（即光感受器外节）体积、EZ-RPE 中央小区域厚度（CST）、总 EZ 衰减、SHRM 体积、SHRM CST 和总 sub-RPE 体积的变化。评估了每次就诊时这些测量值与最佳矫正视力（BCVA）之间的相关性。
结果
从第 4 周到第 56 周，每次就诊时 EZ-RPE 体积和 EZ-RPE CST 均显示出显著增加，而总 EZ 衰减、SHRM 体积、SHRM CST 和总 sub-RPE 体积均显示出显著下降（每次就诊时 P<0.05）。在大多数就诊时，EZ 完整性测量值和 SHRM 体积与 BCVA 显著相关（P<0.05）。总 sub-RPE 体积与 BCVA 之间未发现显著相关性。
结论
nAMD 患者的 EZ 完整性、SHRM 和 sub-RPE 疾病特征在抗 VEGF 治疗后 4 周内即可改善。EZ 完整性测量值和 SHRM 体积是治疗第一年视力的预测指标。
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