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Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension

2026年6月9日 更新者:Brett King、Indiana University

Adaptive Optics Gonioscopy In Vivo Imaging of the Effects of Rhopressa on the Trabecular Meshwork in Patients With Ocular Hypertension or Glaucoma

This study evaluates the effects of netarsudil (Rhopressa) on the trabecular meshwork in subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized to receive either netarsudil or placebo (artificial tears). High-resolution imaging using adaptive optics gonioscopy, anterior segment optical coherence tomography (AS-OCT), and OCT gonioscopy will be performed at baseline and after approximately 14 days of treatment. The primary objective is to assess changes in trabecular meshwork lamellae spacing, with secondary measures including trabecular meshwork height, width, and Schlemm's canal diameter.

研究概览

详细说明

Glaucoma is a leading cause of irreversible blindness and is characterized by progressive optic neuropathy. A major modifiable risk factor is elevated intraocular pressure, which is largely regulated by aqueous humor outflow through the trabecular meshwork. Netarsudil (Rhopressa), a Rho kinase inhibitor, lowers intraocular pressure in part by increasing trabecular outflow and has been shown in preclinical studies to induce structural changes in trabecular meshwork cells and tissues. However, in vivo human data evaluating these effects remain limited.

This prospective, randomized, single-masked study will enroll approximately 50 subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized in a 2:1 ratio to receive either netarsudil ophthalmic solution or placebo (artificial tears). Subjects may undergo a washout period if currently treated with glaucoma medications.

Imaging will be performed using adaptive optics gonioscopy to visualize trabecular meshwork microstructure, as well as anterior segment optical coherence tomography (AS-OCT) and OCT gonioscopy to assess clinically relevant anatomical parameters. Imaging will occur at baseline and after approximately 14-21 days of treatment.

The primary outcome is the change in trabecular meshwork lamellae spacing. Secondary outcomes include changes in trabecular meshwork height and width. Exploratory outcomes include Schlemm's canal diameter and trabecular meshwork endothelial cell counts. These measurements aim to provide in vivo evidence of the structural effects of netarsudil on the aqueous outflow pathway and improve understanding of its mechanism of action in humans.

研究类型

介入性

注册 (估计的)

50

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Brett J King, OD
  • 电话号码:(812) 855-1344
  • 邮箱:kingbrj@iu.edu

学习地点

    • Indiana
      • Bloomington、Indiana、美国、47405
        • 招聘中
        • Indiana Universtiy School of Optometry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosis of ocular hypertension or open-angle glaucoma
  • Eye examination within the past year
  • For glaucoma subjects: structural (optic nerve and/or retinal nerve fiber layer) and functional (visual field) findings consistent with glaucoma
  • Best-corrected visual acuity of 20/100 or better
  • Open anterior chamber angle as confirmed by gonioscopy and anterior segment optical coherence tomography (AS-OCT)
  • Intraocular pressure between 18 and 34 mmHg (treatment-naïve or after washout, if applicable)

Exclusion Criteria:

  • Known intolerance to netarsudil ophthalmic solution
  • Corneal scarring or active corneal disease that would interfere with imaging
  • Inability to tolerate gonioscopy procedures
  • Females of childbearing potential who are not using effective contraception or are not sterile
  • Any condition that, in the opinion of the investigator, would place the subject at increased risk or interfere with study completion

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Netarsudil (Rhopressa)
Participants will receive netarsudil ophthalmic solution administered as one drop in the study eye once daily in the evening for approximately 14 days.
Netarsudil ophthalmic solution is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, it will be administered once daily in the evening for approximately 14 days.
安慰剂比较:Placebo (Artificial Tears)
Participants will receive artificial tears administered as one drop in the study eye once daily in the evening for approximately 14 days.
Artificial tears will be used as a placebo control and administered once daily in the evening for approximately 14 days. These drops are not expected to lower intraocular pressure or alter trabecular meshwork structure.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Trabecular Meshwork Lamellae Spacing
大体时间:Baseline to 14-21 days after initiation of treatment
Mean change in trabecular meshwork lamellae spacing measured using adaptive optics gonioscopy. Measurements will be obtained from baseline (after washout if applicable) and compared to measurements after treatment.
Baseline to 14-21 days after initiation of treatment

次要结果测量

结果测量
措施说明
大体时间
Change in Trabecular Meshwork Height
大体时间:Baseline to 14-21 days after initiation of treatment
Mean change in trabecular meshwork height measured using anterior segment optical coherence tomography (AS-OCT) and OCT gonioscopy. Height is defined as the distance between the scleral spur and Schwalbe's line.
Baseline to 14-21 days after initiation of treatment
Change in Trabecular Meshwork Width
大体时间:Baseline to 14-21 days after initiation of treatment
Mean change in trabecular meshwork width measured using AS-OCT and OCT gonioscopy. Width is defined as the thickness of the trabecular meshwork from the inner wall of Schlemm's canal to the inner surface of the trabecular meshwork.
Baseline to 14-21 days after initiation of treatment

其他结果措施

结果测量
措施说明
大体时间
Change in Schlemm's Canal Diameter
大体时间:Baseline to 14-21 days after initiation of treatment
Mean change in Schlemm's canal cross-sectional diameter measured using AS-OCT and OCT gonioscopy.
Baseline to 14-21 days after initiation of treatment
Trabecular Meshwork Endothelial Cell Counts
大体时间:Baseline and 14-21 days after initiation of treatment
Trabecular meshwork endothelial cell counts measured using adaptive optics gonioscopy. Cell counts will be assessed at baseline and may be compared between groups and correlated with intraocular pressure changes.
Baseline and 14-21 days after initiation of treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月5日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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