Ranibizumab for the Inhibition of Neovascularization in Pterygia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 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 pterygium surgery.
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 pterygium surgery.
详细描述
As a secondary objective, this study also aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection in patients undergoing pterygium excision and to determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •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 with pterygia will be considered for enrollment if the pterygium meets standard pterygium excision criteria including encroachment into the visual axis
- •severe induced astigmatism
- •foreign body sensation unresponsive to medical therapy.
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 pterygium
- •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
1
Patients will receive one injection of ranibizumab 3 days prior to surgery
干预措施: ranibizumab (Drug)
2
Patients will undergo one injection of ranibizumab at the time of surgery
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 pterygium surgery.
时间窗: 2 years
次要结局
- This study aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection and determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.(2 years)