A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to corneal clearance
研究概览
简要总结
Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy.
Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal.
The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
- •Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
- •Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
- •Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
- •The peripheral cornea to the central 6mm is devoid of guttata changes.
- •Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.
排除标准
- •Uncontrolled glaucoma (IOP >25 mmHg).
- •Presence of secondary corneal pathology such as infective or autoimmune keratitis.
- •Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.
- •History of herpes simplex virus or cytomegalovirus keratitis.
- •Prior penetrating keratoplasty.
- •Aphakic in study eye.
- •Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study.
- •Tubes or trabeculectomy from prior glaucoma surgery.
研究组 & 干预措施
Glanatec
Glanatec eye drops will be administered 6x per day for 2-4 weeks
干预措施: Glanatec (Drug)
Glanatec
Glanatec eye drops will be administered 6x per day for 2-4 weeks
干预措施: Descemet Membrane Endothelial Keratoplasty (Procedure)
Placebo Control
Optive artificial tears will be administered 6x per day for 2-4 weeks
干预措施: Optive, Ophthalmic Solution (Drug)
Placebo Control
Optive artificial tears will be administered 6x per day for 2-4 weeks
干预措施: Descemet Membrane Endothelial Keratoplasty (Procedure)
结局指标
主要结局
Time to corneal clearance
时间窗: 6 months
Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.
次要结局
- Post surgery complications(6 months)
- Endothelial cell density(6 months)
- Best corrected visual acuity(6 months)
研究者
Michael D. Straiko, MD
Associate Director of Corneal Services, Devers Eye Institute
Legacy Health System