Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in GC soma density (cells/mm²)
研究概览
简要总结
The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain.
Participants in this study will complete a total of 6 study visits over 12 months:
- Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly.
- At scheduled study visits, researchers will examine participants' eyes and measure eye pressure.
- Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT).
- Participants will also complete specialized visual field testing to measure eye function.
Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.
详细描述
Glaucoma is a chronic, progressive optic neuropathy characterized by functional and structural alterations, specifically the degeneration and loss of retinal ganglion cells (RGCs). Currently, the main modifiable factor for intervention is aimed at lowering intraocular pressure (IOP). While IOP reduction slows disease progression, it does not halt neurodegeneration. Rho kinase (ROCK) inhibitors have been reported to provide benefit in neurodegenerative diseases. Netarsudil ophthalmic solution (Rhopressa) is a ROCK inhibitor approved for the treatment and management of open-angle glaucoma that lowers IOP and has reported protective effects on neural tissue. However, previous attempts to illustrate true cell loss or protection using clinical instrumentation have not demonstrated an effect to date.
High-resolution retinal imaging based on adaptive optics optical coherence tomography (AO-OCT) enables direct visualization, tracking, and quantification of individual ganglion cell layer (GCL) somas in the living human eye. Leveraging the unique imaging capabilities and extraordinary sensitivity of ultra-high-speed AO-OCT, this study will test the hypothesis that treatment with netarsudil is more effective at reducing glaucomatous ganglion cell loss while producing comparable intraocular pressure reduction to that of the comparator.
This prospective, randomized, investigator-masked, cross-over pilot study will compare RGC survival rates between two treatment groups (Rhopressa and Timolol). Thirteen subjects with open-angle glaucoma will be recruited. Following a screening assessment and medication washout period based on drug class, eligible subjects are randomized 1:1 into two age-matched cohorts:
- Cohort 1: Receives Rhopressa (one drop once at night) for 6 months, then crosses over to receive Timolol 0.25% (one drop twice a day) for 6 months.
- Cohort 2: Receives Timolol 0.25% (one drop twice a day) for 6 months, then crosses over to receive Rhopressa (one drop once at night) for 6 months.
At Visit 2 (baseline), Visit 4 (6 months), and Visit 6 (12 months), subjects undergo imaging using the Indiana AO-OCT system along with Goldmann applanation tonometry, standard clinical OCT, and OCT-guided microperimetry (MP-3). AO-OCT imaging is performed at the same retinal regions surrounding arcuate defects to enable longitudinal cellular-level analysis. Primary and secondary endpoints evaluate differences in the rate of change of RGC soma density, individual RGC counts, and GCL thickness between treatment periods.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 其他
- 盲法
- 双盲 (研究者、结局评估者)
盲法说明
This is a investigator-masked study. Randomization will occur from an unmasked key personnel member on the study. The principal investigator and other key members of the study will be masked. Unmasked personnel maintain the randomization schedule and manage drug distribution, but have no role in clinical evaluations, AO-OCT image acquisition, ganglion cell counting, or outcome data analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- All subjects will be 18 years of age or older
- Subjects must be diagnosed with open-angle glaucoma and have had an eye exam within the past year
- Subjects with glaucoma will have structural (optic nerve and retinal nerve fiber layer) and functional (visual field testing) defects consistent with the diagnosis of glaucoma
- Subjects will have a corrected acuity of 20/50 or better and be able to fixate
- Naïve to medication subjects or post washout IOP between 18 and 34 mmHg
- Spherical equivalent from +3 diopters to -6 diopters, with a cylinder of <-3 diopters
- Subject is willing and able to comply with the protocol requirements and to remain in the study for its full duration, including all scheduled visits and follow-up assessments
排除标准
- Subjects with a known intolerance to netarsudil ophthalmic solution
- Subjects with a known intolerance to, or contraindication for, timolol maleate
- Any subject whom the investigator determines to be at unacceptable risk for the washout or believes is unlikely to complete the study
- Subjects with retinal disease or optic neuropathies other than glaucoma that, in the opinion of the investigator, could confound the study assessments or outcome
- Female subjects who are pregnant, breastfeeding, or of childbearing age who are not sterile or using an acceptable method of contraception during the study
研究组 & 干预措施
Rhopressa first, then Timolol
Participants will instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the remaining 6 months (Months 6-12).
干预措施: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] (Drug)
Rhopressa first, then Timolol
Participants will instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the remaining 6 months (Months 6-12).
干预措施: Timolol Maleate 0.25% Ophthalmic Solution (Drug)
Timolol first, then Rhopressa
Participants will instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the remaining 6 months (Months 6-12).
干预措施: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] (Drug)
Timolol first, then Rhopressa
Participants will instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the remaining 6 months (Months 6-12).
干预措施: Timolol Maleate 0.25% Ophthalmic Solution (Drug)
结局指标
主要结局
Change in GC soma density (cells/mm²)
时间窗: Baseline, 6 months, and 12 months
Change in ganglion cell (GC) soma density during treatment with timolol versus netarsudil (Rhopressa)
次要结局
- Changes in GC soma counts (number of cells)(Baseline, 6 months, and 12 months)
- Changes in GCL thickness (micrometers (µm))(Baseline, 6 months, and 12 months)
研究者
Brett King
Clinical Professor
Indiana University
研究点 (1)
标识符
- NCT 编号
- NCT07847073
- 其他研究编号
- 17426-BJKing
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 是否有结果
- 否