An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt® Implantation in Subjects With Chronic Corneal Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 15
- 主要终点
- The frequency of device related adverse events (safety)
研究概览
简要总结
The EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema.The EndoArt® (Artificial Endothelial layer) is a permanent implant, constructed of a clear, transparent, foldable, biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate. The peripheral surface of the EndoArt® has either one or more marks, to ensure the correct orientation of the implant. The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer. Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity.
The EndoArt® device is CE marked approved (approved for marketing by the European regulatory authority).
详细描述
This study is a prospective, multicenter, open-label, phase 2 clinical investigation assessing safety of EndoArt® implantation, in subjects with chronic corneal edema. Safety will be assessed by evaluating the rate of adverse events and adverse device effects throughout the study period. Exploratory efficacy endpoints will be assessed by measuring the change in corneal thickness from baseline, change in pain score from baseline and changes in visual acuity. Time to, and rate of, post-surgical rebubbling to facilitate adhesion of the device will be explored.
Subjects with chronic corneal edema that meet the inclusion/exclusion criteria will be the study target population. The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule. For the Primary endpoint, the frequency and severity of device related adverse events, from patient entry through the 6-month follow-up period will be analyzed. Adverse events will be assessed on a continuous basis and will continue to be collected for 12 months.
This clinical investigation is conducted in up to 12 (twelve) clinical sites in Europe (Germany, France, and Netherlands), Mexico, India and Israel. Additional sites may be considered.
This clinical investigation has been designed to provide continuous clinical evidence for the EndoArt® as part of its clinical follow up program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals must meet the following inclusion criteria at screening visit:
- •Male or Female subjects 40-85 years of age.
- •Have chronic corneal edema (for a minimum of 3 months) secondary to endothelial dysfunction.
- •Have corneal thickness >600μm by OCT.
- •Have best corrected distance visual acuity 6/19 (20/63) or worse (equivalent ETDRS= 60 letters) with subjective symptoms of impaired visual function.
- •Subject with posterior pseudophakia and stable IOL.
- •Willing and able to understand and sign informed consent prior to any study related procedure.
- •Willing and able to follow study instructions (e.g., to lay on one's back for 4 hours post op), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits/assessments for the duration of the study.
排除标准
- •Individuals for participation will be ineligible for the study if any of the following conditions apply:
- •History of ocular Herpetic keratitis.
- •Scarred cornea resulting in visual impairment with intact endothelium (cell density ≥ 1500).
- •History of posterior vitrectomy.
- •Have an irregular posterior cornea (e.g., post trauma).
- •Have a current infection of the cornea.
- •Have band keratopathy and/or limbal stem cell deficiency.
- •Have clinically severe dry eye disease which needs more than 4 drops of lubricant per day.
- •Phthisis bulbi or subject is at risk of developing phthisis.
- •Subject with medically uncontrolled high intra ocular pressure.
- •Anterior chamber IOL or fixated anterior chamber IOL.
- •Pseudophakodonesis.
- •Have large iris defect which could compromise intraoperative air bubble formation
- •Have undergone corneal refractive surgery.
- •History of neurotrophic cornea.
- •History of recurrent corneal erosion or persistent epithelial defect.
- •IridoCorneal Endothelial (ICE) Syndrome or any rare disease/ syndrome creating anatomical or physiological anomalies of the anterior chamber (e.g., corectopia).
- •Recurrent posterior, intermediate or anterior uveitis.
- •Subject receiving regular intravitreal injection
- •Currently participating or have participated in an investigational study, other than this study, within the past 60 days.
结局指标
主要结局
The frequency of device related adverse events (safety)
时间窗: 12 months
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
The severity of device related adverse events (safety).
时间窗: 12 months
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
次要结局
- Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.(12 months)
- Change from baseline in central corneal thickness (CCT) postoperatively.(6 months)
- Incidence of primary post-surgical detachment of the device.(12 months)
- Rate of rebubbling post-op.(12 months)
- Change in ocular pain score as assessed by a Visual Analogue Scale (VAS) from baseline.(12 months)