A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Study on the Use of Rho-Kinase Inhibitor to Reduce Ore Prevent Proliferative Vitreoretinopathy (PVR) in Eyes With Rhegmatogenous Retinal Detachment (RRD) at High Risk of PVR
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Single surgery anatomic success (retinal re-attachment) rate
研究概览
简要总结
The purpose of this study is to determine if a drug called netarsudil is safe and able to prevent the development of scar tissue after retinal detachment repair. Patients eligible for this study are those diagnosed with a rhegmatogenous retinal detachment deemed at high risk for scar tissue formation (a process called 'proliferative vitreoretinopathy').
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •A patient must meet the following criteria to be eligible for inclusion in the study:
- •Diagnosed with primary RRD at high risk for PVR development. Specifically, the enrolled eye must include at least 1 but no more than 3 high risk features, which are designated as follows: multiple retinal breaks (3 or more); detachments involving two or more quadrants of the retina; duration of detachment > 3 weeks; vitreous hemorrhage; and choroidal detachment.
- •Consents to surgical repair with pars plana vitrectomy with or without scleral buckling
- •Willing and able to comply with clinic visits and study-related procedures
- •Able to provide a signed informed consent
排除标准
- •A patient who meets any of the following criteria will be excluded from the study:
- •Age < 18 years
- •Presence of PVR grade B or worse (as defined by the revised Retina Society PVR classification system) at time of surgical repair
- •Primary RRD repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone.
- •Primary use of silicone oil or retinectomy during surgical repair
- •Prior incisional ocular surgery other than cataract extraction
- •History of or concurrent ruptured globe, intraocular foreign body, diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular hole, epiretinal membrane, sickle cell disease, uveitis or intraocular infectious disease
- •Not willing or unable to comply with clinic visits and study-related procedures
- •Unable to provide a signed informed consent
研究组 & 干预措施
Netarsudil 0.02%
For the study arm: one drop of rho-kinase (ROCK) inhibitor in the vitrectomized eye, once daily in the evening starting on postoperative day 1 after RRD repair surgery, till post-operative day 56
干预措施: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] (Drug)
Artificial tears
Patients enrolled in the control group will receive a placebo (one drop of artificial tears) once daily in the evening starting on postoperative day 1 after RRD repair surgery, till post-operative day 56
干预措施: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud (Drug)
结局指标
主要结局
Single surgery anatomic success (retinal re-attachment) rate
时间窗: Six months
Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.
次要结局
- Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points.(Six months)
- The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging(Six months)
- Change from baseline in visual acuity (Snellen) wearing habitual correction.(Six months)
- The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination.(Six months)
研究者
Jason Hsu, MD
Co-Director, Retina Research; Associate Professor, Sidney Kimmel Medical College at Thomas Jefferson University
Wills Eye