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.
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。