Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension
Adaptive Optics Gonioscopy In Vivo Imaging of the Effects of Rhopressa on the Trabecular Meshwork in Patients With Ocular Hypertension or Glaucoma
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
注册 (估计的)
阶段
- 第四阶段
联系人和位置
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
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Indiana
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Bloomington、Indiana、美国、47405
- 招聘中
- Indiana Universtiy School of Optometry
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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 |
|---|---|
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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.
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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.
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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.
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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.
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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 |
|---|---|---|
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Change in Trabecular Meshwork Lamellae Spacing
大体时间:Baseline to 14-21 days after initiation of treatment
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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.
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Baseline to 14-21 days after initiation of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Trabecular Meshwork Height
大体时间:Baseline to 14-21 days after initiation of treatment
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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.
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Baseline to 14-21 days after initiation of treatment
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Change in Trabecular Meshwork Width
大体时间:Baseline to 14-21 days after initiation of treatment
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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.
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Baseline to 14-21 days after initiation of treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Schlemm's Canal Diameter
大体时间:Baseline to 14-21 days after initiation of treatment
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Mean change in Schlemm's canal cross-sectional diameter measured using AS-OCT and OCT gonioscopy.
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Baseline to 14-21 days after initiation of treatment
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Trabecular Meshwork Endothelial Cell Counts
大体时间:Baseline and 14-21 days after initiation of treatment
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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.
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Baseline and 14-21 days after initiation of treatment
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合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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