Abstract：
OBJECTIVE: To examine retinal feature dynamics in eyes with neovascular age-related macular degeneration (nAMD) treated with anti-VEGF therapy and the relationship of these features with visual acuity.
METHODS: Post hoc analysis of the phase III, randomized, HAWK nAMD clinical trial.
METHODS: Participants randomized to the brolucizumab 6 mg or aflibercept 2 mg arms of the trial.
METHODS: Spectral-domain OCT scans collected at 4-week intervals were analyzed using an automated machine learning-enhanced segmentation and feature-extraction platform with manual verification. Quantitative volumetric measures of retinal and exudative features were exported at multiple timepoints over 48 weeks. Volatility of exudative features was calculated as the standard deviation of each feature value during the maintenance phase (week 12-48) of treatment. These features were examined for their associations with anatomic and functional outcomes.
METHODS: Longitudinal intraretinal fluid (IRF) and subretinal fluid (SRF) volume, subretinal hyperreflective material (SHRM) volume, ellipsoid zone (EZ) integrity (EZ-retinal pigment epithelium [RPE] volume/thickness), and correlation with best-corrected visual acuity (BCVA).
RESULTS: Intraretinal fluid, SRF, and SHRM demonstrated significant volumetric reduction from baseline with anti-VEGF therapy (P < 0.001 at each timepoint). Ellipsoid zone integrity measures demonstrated significant improvement from baseline (P < 0.001 at each timepoint). Both EZ integrity and SHRM measures correlated significantly with BCVA at all timepoints (EZ-RPE volume: 0.38 ≤ r ≤ 0.47; EZ-RPE central subfield thickness: 0.22 ≤ r ≤ 0.41; SHRM volume: -0.33 ≤ r ≤ -0.44). After treatment initiation, correlations of IRF and SRF volume with BCVA were weak or nonsignificant. Eyes with lower volatility of IRF, SRF, and SHRM volumes during the maintenance phase showed greater improvements in EZ integrity (all P < 0.01) and greater gains in BCVA (all P < 0.01) at week 48 compared with eyes with higher volatility in those exudative parameters.
CONCLUSIONS: Quantitative measures of SHRM volume and EZ integrity correlated more strongly with BCVA than retinal fluid volumes during treatment. High volatility of exudative parameters, including SRF, during the maintenance phase of treatment was associated with loss of EZ integrity and BCVA.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
METHODS: Post hoc analysis of the phase III, randomized, HAWK nAMD clinical trial.
METHODS: Participants randomized to the brolucizumab 6 mg or aflibercept 2 mg arms of the trial.
METHODS: Spectral-domain OCT scans collected at 4-week intervals were analyzed using an automated machine learning-enhanced segmentation and feature-extraction platform with manual verification. Quantitative volumetric measures of retinal and exudative features were exported at multiple timepoints over 48 weeks. Volatility of exudative features was calculated as the standard deviation of each feature value during the maintenance phase (week 12-48) of treatment. These features were examined for their associations with anatomic and functional outcomes.
METHODS: Longitudinal intraretinal fluid (IRF) and subretinal fluid (SRF) volume, subretinal hyperreflective material (SHRM) volume, ellipsoid zone (EZ) integrity (EZ-retinal pigment epithelium [RPE] volume/thickness), and correlation with best-corrected visual acuity (BCVA).
RESULTS: Intraretinal fluid, SRF, and SHRM demonstrated significant volumetric reduction from baseline with anti-VEGF therapy (P < 0.001 at each timepoint). Ellipsoid zone integrity measures demonstrated significant improvement from baseline (P < 0.001 at each timepoint). Both EZ integrity and SHRM measures correlated significantly with BCVA at all timepoints (EZ-RPE volume: 0.38 ≤ r ≤ 0.47; EZ-RPE central subfield thickness: 0.22 ≤ r ≤ 0.41; SHRM volume: -0.33 ≤ r ≤ -0.44). After treatment initiation, correlations of IRF and SRF volume with BCVA were weak or nonsignificant. Eyes with lower volatility of IRF, SRF, and SHRM volumes during the maintenance phase showed greater improvements in EZ integrity (all P < 0.01) and greater gains in BCVA (all P < 0.01) at week 48 compared with eyes with higher volatility in those exudative parameters.
CONCLUSIONS: Quantitative measures of SHRM volume and EZ integrity correlated more strongly with BCVA than retinal fluid volumes during treatment. High volatility of exudative parameters, including SRF, during the maintenance phase of treatment was associated with loss of EZ integrity and BCVA.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
摘要：
目的：研究抗VEGF治疗新生血管性年龄相关性黄斑变性（nAMD）的视网膜特征动态，以及这些特征与视力的关系。
方法：第三阶段的事后分析，随机化，HAWKnAMD临床试验。
方法：参与者随机分配到6mg的brolucizumab或2mg的阿柏西普治疗组。
方法：使用自动机器学习增强分割和特征提取平台并手动验证，分析每隔4周收集的谱域OCT扫描。在48周内的多个时间点输出视网膜和渗出性特征的定量体积测量。在治疗的维持阶段（第12-48周），将渗出性特征的挥发性计算为每个特征值的标准偏差。检查了这些特征与解剖和功能结果的关联。
方法：纵向视网膜内液（IRF）和视网膜下液（SRF）的体积，视网膜下超反射材料（SHRM）体积，椭圆体区（EZ）完整性（EZ-视网膜色素上皮[RPE]体积/厚度），以及与最佳矫正视力（BCVA）的相关性。
结果：卷内液体，SRF,和SHRM显示出抗VEGF治疗相对于基线的显著体积减少(在每个时间点P<0.001)。椭球区完整性测量显示从基线显著改善(在每个时间点P<0.001)。在所有时间点，EZ完整性和SHRM测量值均与BCVA显着相关（EZ-RPE体积：0.38≤r≤0.47；EZ-RPE中心子场厚度：0.22≤r≤0.41；SHRM体积：-0.33≤r≤-0.44）。治疗开始后，IRF和SRF体积与BCVA的相关性较弱或不显着。IRF波动性较低的眼睛，SRF,与那些渗出性参数的波动性较高的眼睛相比，维持阶段的SHRM体积在48周时显示出EZ完整性的更大改善（所有P<0.01）和BCVA的更大增加（所有P<0.01）。
结论：治疗期间，SHRM体积和EZ完整性的定量测量与BCVA的相关性比视网膜液体积更强。渗出性参数的高波动性，包括SRF，在治疗的维持阶段,与EZ完整性和BCVA的丧失相关.
背景：专有或商业披露可以在本文末尾的脚注和披露中找到。
方法：第三阶段的事后分析，随机化，HAWKnAMD临床试验。
方法：参与者随机分配到6mg的brolucizumab或2mg的阿柏西普治疗组。
方法：使用自动机器学习增强分割和特征提取平台并手动验证，分析每隔4周收集的谱域OCT扫描。在48周内的多个时间点输出视网膜和渗出性特征的定量体积测量。在治疗的维持阶段（第12-48周），将渗出性特征的挥发性计算为每个特征值的标准偏差。检查了这些特征与解剖和功能结果的关联。
方法：纵向视网膜内液（IRF）和视网膜下液（SRF）的体积，视网膜下超反射材料（SHRM）体积，椭圆体区（EZ）完整性（EZ-视网膜色素上皮[RPE]体积/厚度），以及与最佳矫正视力（BCVA）的相关性。
结果：卷内液体，SRF,和SHRM显示出抗VEGF治疗相对于基线的显著体积减少(在每个时间点P<0.001)。椭球区完整性测量显示从基线显著改善(在每个时间点P<0.001)。在所有时间点，EZ完整性和SHRM测量值均与BCVA显着相关（EZ-RPE体积：0.38≤r≤0.47；EZ-RPE中心子场厚度：0.22≤r≤0.41；SHRM体积：-0.33≤r≤-0.44）。治疗开始后，IRF和SRF体积与BCVA的相关性较弱或不显着。IRF波动性较低的眼睛，SRF,与那些渗出性参数的波动性较高的眼睛相比，维持阶段的SHRM体积在48周时显示出EZ完整性的更大改善（所有P<0.01）和BCVA的更大增加（所有P<0.01）。
结论：治疗期间，SHRM体积和EZ完整性的定量测量与BCVA的相关性比视网膜液体积更强。渗出性参数的高波动性，包括SRF，在治疗的维持阶段,与EZ完整性和BCVA的丧失相关.
背景：专有或商业披露可以在本文末尾的脚注和披露中找到。
