Mundorf Eye Center, Charlotte, North Carolina.
Scripps Clinic, La Jolla, California.
Ophthalmol Glaucoma. 2020 Nov-Dec;3(6):421-425. doi: 10.1016/j.ogla.2020.04.014. Epub 2020 Apr 29.
To describe the changes in endothelial cell density (ECD), the coefficient of variation (CV), and the percent of hexagonal cells (%HEX) after 3 months of therapy with netarsudil (Rhopressa; Aerie Pharmaceuticals Inc, Durham, NC) 0.02% dosed once daily (QD) or twice daily (BID) and to compare these changes with those seen with timolol 0.5% BID in eyes with ocular hypertension (OHTN) or open-angle glaucoma (OAG).
Post hoc analysis of data from a phase 3 evaluation of the intraocular pressure (IOP)-lowering efficacy and safety of netarsudil 0.02% versus timolol 0.5%.
A subset of study subjects underwent corneal endothelial cell imaging by specular microscopy at baseline and after 3 months of therapy.
Images were evaluated in a masked fashion at an independent reading center. The ECD, CV, and %HEX were determined using a standardized protocol for image analysis.
Changes in ECD, CV, and %HEX from baseline to 3 months were compared between treatment groups using 2-sample t tests.
Data from 386 subjects from whom analyzable specular microscopy images were obtained at both baseline and month 3 were included in this analysis. Mean ECD, CV, and %HEX values were comparable between groups at baseline. There were no statistically significant between-group differences in changes from baseline to month 3 in ECD, CV, or %HEX between either of the netarsudil groups and the timolol group. Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all 3 groups by 1.4% to 2.1% (P < 0.001), and %HEX increased by a statistically significant amount (0.7%, P = 0.030) in the timolol group. These small changes were unlikely to be of clinical significance. No statistically significant changes in ECD were seen in any group.
Netarsudil 0.02% showed no clinically significant effects on ECD, CV, or %HEX when dosed QD or BID for 3 months in eyes with OHTN or OAG.
描述内皮细胞密度（ECD）、变异系数（CV）和六边型细胞百分比（%HEX）在使用 netarsudil（Aerie 制药公司，北卡罗来纳州达勒姆）0.02%QD 或 BID 治疗 3 个月后的变化，并与他氟前列素 0.5%BID 治疗眼内高压（OHTN）或开角型青光眼（OAG）的变化进行比较。
这是一项对 netarsudil 0.02%降低眼压的疗效和安全性进行的 3 期评估的事后分析，研究比较了 netarsudil 与他氟前列素。
在基线和治疗 3 个月后，一组研究对象接受了角膜内皮细胞的共焦显微镜检查。
在一个独立的阅读中心以盲法评估图像。使用图像分析的标准化方案确定 ECD、CV 和%HEX。
使用两样本 t 检验比较治疗组从基线到 3 个月 ECD、CV 和%HEX 的变化。
纳入了 386 名在基线和 3 个月时均获得可分析的共焦显微镜图像的受试者的数据。在基线时，各组的 ECD、CV 和%HEX 值相似。从基线到 3 个月，与他氟前列素组相比，netarsudil 组之间的 ECD、CV 或%HEX 变化无统计学显著差异。在所有 3 组中，CV 从基线到 3 个月呈统计学显著下降，降幅为 1.4%至 2.1%（P<0.001），%HEX 呈统计学显著增加（0.7%，P=0.030）。这些微小的变化不太可能具有临床意义。任何一组的 ECD 均无统计学显著变化。
在 OHTN 或 OAG 患者中，使用 netarsudil 0.02%QD 或 BID 治疗 3 个月，对 ECD、CV 或%HEX 无明显临床影响。
