Sheth Veeral, D'Rozario Mitchell, Gune Shamika, Blotner Steven
University Retina and Macula Associates, Lemont, Illinois, USA.
Genentech, Inc, South San Francisco, California, USA.
BMJ Open Ophthalmol. 2022 Mar 9;7(1):e000957. doi: 10.1136/bmjophth-2021-000957. eCollection 2022.
To evaluate correlations between variability in central foveal thickness (CFT) and vision with ranibizumab in a HARBOR post hoc analysis.
Patients with neovascular age-related macular degeneration (nAMD; N=1097) received monthly or as-needed (PRN) ranibizumab (0.5 or 2.0 mg) for 24 months. Fluctuation scores were used to assess CFT variability; every time CFT increased and then decreased (or vice versa), numeric value of the change was added to the score. Magnitude of change <50 µm was considered clinically insignificant and did not count towards the score. Fluctuation scores were grouped into quartiles. Least squares mean (LSM) changes in best-corrected visual acuity (BCVA) were plotted against fluctuation score quartiles for CFT, subretinal fluid (SRF) height, neurosensory retina and neurosensory retina + subretinal hyper-reflective material.
Patients with lower fluctuations scores (quartiles 1-3) had greatest vision gains at month 24, with LSM changes from baseline of 9.0-10.8 and 8.7-10.6 letters in the monthly and PRN arms, respectively. Corresponding changes for quartile 4 were 6.7 and 6.5 letters, respectively. There were no differences between quartiles for association between fluctuations in SRF height and BCVA gains. There were inverse correlations between magnitude of fluctuations in neurosensory and inner retina thickness and BCVA gains for quartile 4 vs quartiles 1-3. Patients in quartiles 1 and 2 showed rapid, robust BCVA gains, whereas those in quartiles 3 and 4 had lesser responses.
Fluctuations in retinal thickening with ranibizumab may be associated with treatment response in patients with nAMD.
NCT00891735.
在一项HARBOR事后分析中评估雷珠单抗治疗时中心凹厚度（CFT）变异性与视力之间的相关性。
患有新生血管性年龄相关性黄斑变性（nAMD；N = 1097）的患者接受每月或按需（PRN）注射雷珠单抗（0.5或2.0 mg），持续24个月。波动评分用于评估CFT变异性；每次CFT先升高后降低（或反之）时，变化的数值会加到评分中。变化幅度<50 µm被认为在临床上无显著意义，不计入评分。波动评分被分为四分位数。将最佳矫正视力（BCVA）的最小二乘均值（LSM）变化与CFT、视网膜下液（SRF）高度、神经感觉视网膜以及神经感觉视网膜 + 视网膜下高反射物质的波动评分四分位数进行绘制。
波动评分较低（四分位数1 - 3）的患者在第24个月时视力改善最大，每月给药组和PRN给药组从基线的LSM变化分别为9.0 - 10.8和8.7 - 10.6字母。四分位数4的相应变化分别为6.7和6.5字母。SRF高度波动与BCVA改善之间的关联在四分位数之间没有差异。四分位数4与四分位数1 - 3相比，神经感觉和视网膜内层厚度的波动幅度与BCVA改善之间存在负相关。四分位数1和2的患者BCVA迅速、显著提高，而四分位数3和4的患者反应较小。
雷珠单抗治疗时视网膜增厚的波动可能与nAMD患者的治疗反应相关。
NCT00891735。
