A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The goal of this clinical trial is to learn if PVEK, a corneal implant , is safe and well tolerated for people with corneal swelling caused by Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty.
The main questions it aims to answer are:
What side effects may happen after the PVEK implant?
How many participants can complete the first 6 months after surgery without needing another treatment because the implant did not help enough or was not tolerable?
This is a Phase 1 (first-in-human) study with one study group, meaning all participants receive the PVEK implant (there is no placebo or comparison group). About 15 participants will take part and will be followed for up to 12 months after surgery.
Participants will:
Complete screening tests (including eye exams and routine health checks)
Have the PVEK implantation surgery
Use prescribed eye drops after surgery
Return for follow-up visits over the next 12 months for eye exams and tests (such as vision testing, eye pressure checks, and eye scans)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •age 18/50 years or older
- •Corneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and/or pseudophakic bullous keratopathy
- •Pseudophakic study eye
- •Best corrected visual acuity (BCVA) in the study eye between 6/379 (1.8 logMAR) and 6/12 (0.3 logMAR)
- •Central corneal thickness greater than 0.6 mm by OCT
排除标准
- •Phakic study eye
- •Study eye is a "single sight eye" (per protocol definition) / fellow eye does not meet protocol vision requirement
- •Malpositioned intraocular lens (dislocation/subluxation) in the study eye
- •Prior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL
- •Axial length below 21 mm or above 26 mm
- •Other significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring/opacities not expected to improve with treatment
- •Active ocular or eyelid infection/inflammation; active/prior herpetic ocular infection; uveitis
- •Glaucoma / history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye)
- •Synechiae; abnormal anterior segment (e.g., aphakia, aniridia)
- •Corneal endothelial cell density above 1000 cells/mm² at screening (or not reliably measurable)
- •Uncontrolled systemic conditions
研究组 & 干预措施
PVEK
Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration
干预措施: Precise Vision Endothelial Keratoplasty (PVEK) Implant (Combination Product)
结局指标
主要结局
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
时间窗: 6 months
Number and percentage of participants with any adverse event (AE) and any treatment-emergent adverse event (TEAE) occurring after PVEK implantation.
Proportion of participants completing 6-month follow-up without seeking alternative treatment
时间窗: 6 months
Percentage of participants who complete the 6-month follow-up without seeking alternative treatment due to perceived lack of efficacy or intolerability of side effects.
次要结局
- BCVA(12 months)
- Corneal endothelial cell density(6 and 12 months)
- Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation(6-12 months)
- Elevated IOP(12 months)
- Central corneal thickness(12 months)