Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Primary Rhegmatogenous Detachments and Retinal Detachment Due to Proliferative Vitreoretinopathy or Open-Globe Injury: A Phase I/II Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.
研究概览
简要总结
This study has two main objectives. The first objective is to study the pharmacokinetics of topical netarsudil administration in the posterior segment of the eye, where netarsudil must exert its effect in order to prevent formation of tractional membranes.
The second objective is to assess the safety profile of topical netarsudil in the pre- and post-operative periods. A secondary objective of the study is to begin to assess signs of efficacy in preventing formation of tractional membranes post-operatively.
详细描述
This is an open-label, randomized study that will test the safety and pharmacokinetics of topical netarsudil at a dose frequency of once-daily in two cohorts of patients: those with primary rhegmatogenous detachments, and those with established proliferative vitreoretinopathy. The intervention will be topical application of Netarsudil from time of diagnosis of retinal detachment to 16 weeks post-operatively.
Patients will be randomized to one of the following groups:
- The primary rhegmatogenous detachment cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil.
- The proliferative vitreoretinopathy cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil.
After surgery, patients will continue on once per day dosing of Netarsudil for a total of 16 weeks post-op.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Primary retinal detachment, Phakic group
Phakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included.
Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
干预措施: Netarsudil Ophthalmic (Drug)
Primary retinal detachment, Pseudophakic group
Pseudophakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included.
Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
干预措施: Netarsudil Ophthalmic (Drug)
Secondary retinal detachment, Phakic group
Phakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included.
Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
干预措施: Netarsudil Ophthalmic (Drug)
Secondary retinal detachment, Pseudophakic group
Pseudophakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included.
Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
干预措施: Netarsudil Ophthalmic (Drug)
结局指标
主要结局
The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.
时间窗: Through study completion, an average of 1 year
Netarsudil concentration in the posterior segment of the eye, using High-performance liquid chromatography (HPLC)
Serious adverse events
时间窗: Day 1, 7, 28, 84, and 168 after surgery
Unexpected serious adverse events
次要结局
- Number of operations within 3 months(Day 84 after surgery)
- Final attachment status at last follow-up(Day 168 after surgery)
- Visual acuity(Day 1, 7, 28, 84, and 168 after surgery)
- Spectral domain optical coherence tomography (SD-OCT) of the macula(Day 1, 7, 28, 84, and 168 after surgery)
- Adverse events(Day 1, 7, 28, 84, and 168 after surgery)
研究者
Leo Am Kim, M.D.
Assistant Professor of Ophthalmology
Massachusetts General Hospital