NCT00512876已完成不适用
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Adverse Events (Ocular and Systemic)
研究概览
简要总结
Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor, bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal neovascularization.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, at least 18 years of age
- •clinically stable corneal neovascularization
- •superficial or deep corneal neovascularization that extends farther than 2mm from the limbus
- •ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits.
- •Clinical stability - all of the following criterial should be excluded before a corneal neovascularization can be regarded as clinically stable:
- •current or recent (<3 months) episode of corneal and ocular surface infection (bacterial, viral, fungal, or acanthamoebal)
- •recent (<3 months) ocular surgery, including cataract surgery, and/or laser of any type in the study eye
- •recent (<6 months) full thickness or lamellar keratoplasty
- •recent (<6 months) ocular surface reconstruction, limbal auto or allograft stem cell transplantation, or amniotic membrane transplantation
- •current or recent (<3 months) use of contact lens or plan to use contact lens (excluding bandage contact lens)
- •current or recent (<3 months) persistent corneal epithelial defect (of at leat 14 days duration) measuring more than 1mm2
排除标准
- •current or recent (<1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye
- •current or recent (<3 months) intravitreal durg injection to the study eye.
- •recent (<1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents
- •uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure of >90 mmHg
- •history of a thromboembolic event, including myocardial infarction or cerebral vascular accident
- •patients age 75 or older
- •history of renal abnormalities
- •recent (<3 months) or planned surgery
- •history of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin or similar anticoagulant agent)
- •all female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.
- •any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
- •any condition that precludes the patient's ability or an assisting family member's ability to apply the medication drops or to sustain five minutes of pressure on the lacrimal ducts after drop application.
- •concurrent enrollment in another clinical investigation medicinal product or device study is prohibited.
结局指标
主要结局
Adverse Events (Ocular and Systemic)
时间窗: 24 weeks
次要结局
- Size and Extent of Corneal Neovascularization(24 weeks)
研究者
Michael J. Mines, MD
Research Director, Ophthalmology
Walter Reed Army Medical Center
研究点 (2)
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