Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.
研究概览
简要总结
The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.
详细描述
As a secondary objective, this study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally at the limbus in patients undergoing corneal transplantation. The effects of ranibizumab on corneal epithelial healing will be examined following adjunctive use in corneal transplantation. Finally, clinical characteristics including recurrent corneal neovascularization will be studied.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible if the following criteria are met:
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 18 years
- •Patient related considerations
- •All patients of both genders will be considered for enrollment.
- •Disease related considerations
- •Patients meeting accepted criteria for undergoing corneal transplantation will be considered if peripheral corneal neovascularization exists in 2 or more contiguous clock hours
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Pregnancy (positive pregnancy test)
- •Women seeking to become pregnant
- •Lactating women
- •Prior enrollment in the study
- •Prior glaucoma surgery in the region of the corneal neovascularization
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
研究组 & 干预措施
Ranibizumab
Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally
干预措施: Ranibizumab (Drug)
结局指标
主要结局
The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.
时间窗: 2 years
次要结局
- This study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally. The effects of ranibizumab on corneal epithelial healing and prevention of recurrent neovascularization will be examined.(2 years)