PDF(Pubmed)
Abstract：
To evaluate the incidence of bacillary layer detachment among patients with neovascular age-related macular degeneration (nAMD) and their response to anti-VEGF therapy.
Post hoc analysis of the OSPREY clinical trial, a prospective, double-masked, phase II study comparing 6-mg brolucizumab with 2-mg aflibercept over 56 weeks.
Participants with treatment-naive nAMD at the initiation of the trial were included in the analysis (n = 81).
Spectral-domain OCT (SD-OCT) scans were obtained at 4-week intervals throughout the OSPREY study and were segmented automatically using a proprietary, machine learning-enabled higher-order feature-extraction platform.
The presence of bacillary detachment, and in these eyes the effect of anti-VEGF therapy on change from baseline in visual acuity (VA), central subfield thickness (CST), retinal fluid volumes, subretinal hyper-reflective material (SHRM) volume, subretinal pigment epithelium (sub-RPE) fluid volume, and ellipsoid zone (EZ) integrity at week 56.
Bacillary detachment was identified in 7.4% (6 of 81) eyes, which had higher fluid volumes, increased CST, EZ attenuation, and increased sub-RPE volume at baseline compared with eyes without bacillary detachment. Anti-VEGF treatment resulted in the resolution of bacillary detachment in 100% of the eyes. In eyes with bacillary detachment at baseline, the anti-VEGF treatment decreased CST, fluid burden, and SHRM volumes throughout the treatment course; however, there was no significant change from baseline in VA, sub-RPE volume, or EZ integrity throughout the 56-week course of anti-VEGF treatment.
Bacillary detachment is an OCT signature that is identifiable in a notable proportion of nAMD eyes. Anti-VEGF therapy resulted in 100% resolution of bacillary detachment and significant decreases in CST and SHRM volume; however, improvements in VA may have been limited by persistent EZ attenuation.
Post hoc analysis of the OSPREY clinical trial, a prospective, double-masked, phase II study comparing 6-mg brolucizumab with 2-mg aflibercept over 56 weeks.
Participants with treatment-naive nAMD at the initiation of the trial were included in the analysis (n = 81).
Spectral-domain OCT (SD-OCT) scans were obtained at 4-week intervals throughout the OSPREY study and were segmented automatically using a proprietary, machine learning-enabled higher-order feature-extraction platform.
The presence of bacillary detachment, and in these eyes the effect of anti-VEGF therapy on change from baseline in visual acuity (VA), central subfield thickness (CST), retinal fluid volumes, subretinal hyper-reflective material (SHRM) volume, subretinal pigment epithelium (sub-RPE) fluid volume, and ellipsoid zone (EZ) integrity at week 56.
Bacillary detachment was identified in 7.4% (6 of 81) eyes, which had higher fluid volumes, increased CST, EZ attenuation, and increased sub-RPE volume at baseline compared with eyes without bacillary detachment. Anti-VEGF treatment resulted in the resolution of bacillary detachment in 100% of the eyes. In eyes with bacillary detachment at baseline, the anti-VEGF treatment decreased CST, fluid burden, and SHRM volumes throughout the treatment course; however, there was no significant change from baseline in VA, sub-RPE volume, or EZ integrity throughout the 56-week course of anti-VEGF treatment.
Bacillary detachment is an OCT signature that is identifiable in a notable proportion of nAMD eyes. Anti-VEGF therapy resulted in 100% resolution of bacillary detachment and significant decreases in CST and SHRM volume; however, improvements in VA may have been limited by persistent EZ attenuation.
摘要：
目的：评估新生血管性年龄相关性黄斑变性（nAMD）患者菌层脱离的发生率及其对抗VEGF治疗的反应。
方法：OSPREY临床试验的事后分析，一个潜在的，双面蒙面,II期研究比较了56周内6-mg的溴珠单抗和2-mg的阿柏西普。
方法：在试验开始时接受治疗的nAMD参与者被纳入分析（n=81）。
方法：在整个OSPREY研究中，以4周的间隔获得谱域OCT（SD-OCT）扫描，支持机器学习的高阶特征提取平台。
方法：细菌脱离的存在，在这些眼睛中，抗VEGF治疗对视敏度（VA）从基线变化的影响，中心子场厚度（CST），视网膜液体积,视网膜下高反射材料（SHRM）体积，视网膜下色素上皮（sub-RPE）液体量，和第56周时的椭球区(EZ)完整性。
结果：在7.4%（81个中的6个）的眼中发现细菌脱离，液体体积较高，CST增加，EZ衰减,与没有细菌脱离的眼睛相比，基线下RPE体积增加。抗VEGF治疗导致100%眼睛的细菌脱离的消退。基线时出现细菌脱离的眼睛,抗VEGF治疗降低了CST，流体负荷，和SHRM在整个治疗过程中的数量；然而，VA与基线相比没有显著变化，子RPE卷，或EZ完整性在整个56周的抗VEGF治疗过程。
结论：细菌脱离是一种OCT特征，在相当比例的nAMD眼中可以识别。抗VEGF治疗导致100%的细菌分离和CST和SHRM体积的显著减少;然而,VA的改善可能受到持续EZ衰减的限制。
方法：OSPREY临床试验的事后分析，一个潜在的，双面蒙面,II期研究比较了56周内6-mg的溴珠单抗和2-mg的阿柏西普。
方法：在试验开始时接受治疗的nAMD参与者被纳入分析（n=81）。
方法：在整个OSPREY研究中，以4周的间隔获得谱域OCT（SD-OCT）扫描，支持机器学习的高阶特征提取平台。
方法：细菌脱离的存在，在这些眼睛中，抗VEGF治疗对视敏度（VA）从基线变化的影响，中心子场厚度（CST），视网膜液体积,视网膜下高反射材料（SHRM）体积，视网膜下色素上皮（sub-RPE）液体量，和第56周时的椭球区(EZ)完整性。
结果：在7.4%（81个中的6个）的眼中发现细菌脱离，液体体积较高，CST增加，EZ衰减,与没有细菌脱离的眼睛相比，基线下RPE体积增加。抗VEGF治疗导致100%眼睛的细菌脱离的消退。基线时出现细菌脱离的眼睛,抗VEGF治疗降低了CST，流体负荷，和SHRM在整个治疗过程中的数量；然而，VA与基线相比没有显著变化，子RPE卷，或EZ完整性在整个56周的抗VEGF治疗过程。
结论：细菌脱离是一种OCT特征，在相当比例的nAMD眼中可以识别。抗VEGF治疗导致100%的细菌分离和CST和SHRM体积的显著减少;然而,VA的改善可能受到持续EZ衰减的限制。
