An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Ocular and Systemic Safety: occurrence of ocular and systemic adverse events
研究概览
简要总结
The first stage of this study will evaluates the tolerability of different concentrations of Conbercept eye drop to patients with corneal neovascularization.
The second stage of this study will evaluate the effectiveness of conbercept eye drop initially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent form, volunteered to participate in the trial and followed up according to the protocol.
- •Ages from 18 to 75,male or female.
- •Superficial or deep neovascularization induced by trauma/chemical burn/inflammation/corneal transplantation.
排除标准
- •Subjects who had significant defect in the corneal epithelium.
- •Study eye had been injected of anti-vegf drugs within 3 months before screening
- •Study eye was performed surgery (except keratoplasty) within 3 months prior screening, or eye surgery was planned during this trial period.
- •Oral glucocorticoid administration within 1 month prior screening (except for duration less than 7 days)
- •Systemic use of anti-vegf drugs within 45 days prior to screening.
- •Have history of abnormal coagulation, such as end-stage liver disease, or are taking anticoagulants（except aspirin）.
- •Uncontrolled clinical problems such as canner etc..
- •Unable or unwilling to use effective contraception.
- •Positive blood tests for pregnancy (female subjects)
- •Participated in drug clinical trials within 3 months before the first administration.
- •The researchers think the participants were not suitable for this trail.
研究组 & 干预措施
Conbercept eye drop (0.1mg/ mL)
Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time.
干预措施: Conbercept eye drop (Drug)
Conbercept eye drop (0.5mg/ mL)
Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.
干预措施: Conbercept eye drop (Drug)
Conbercept eye drop (0.5mg/ mL)
Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.
干预措施: Placebo (Drug)
Conbercept eye drop (1.0mg/ mL)
Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.
干预措施: Conbercept eye drop (Drug)
Conbercept eye drop (1.0mg/ mL)
Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular and Systemic Safety: occurrence of ocular and systemic adverse events
时间窗: day 14
The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations. Systemic adverse events were identified with physical examinations.
次要结局
- The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study(day 14 and day 28)