Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Ocular Adverse Event
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
详细描述
This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.
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
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 18 years old
- •Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus
排除标准
- •Has received investigational therapy within 60 days prior to study entry
- •Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
- •Concurrent use of systemic anti-VEGF agents
- •Full thickness or lamellar keratoplasty within 90 days prior to study entry
- •Ocular surface reconstruction within 90 days prior to study entry
- •Other ocular surgeries within 90 days prior to study entry
- •Corneal or ocular surface infection within 90 days prior to study entry
- •Ocular or periocular malignancy
- •Contact lens (excluding bandage contact lens) within 30 days prior to study entry
- •Persistent epithelial defect (>1mm2 and ≥14 days duration) within 30 days prior to study entry
- •Systemic, intravitreal, or periocular steroids within 30 days prior to study entry
- •Change in dose/frequency of topical steroids and/or NSAIDs within 30 days prior to study entry
- •Hypertension: systolic BP > 150 or diastolic BP > 90
- •History of thromboembolic event within 6 months prior to study entry
- •Current diagnosis of diabetes, Pregnancy (positive pregnancy test) or lactation
- •Premenopausal women not using adequate contraception (The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch)
- •Participation in another simultaneous medical investigation or trial.
研究组 & 干预措施
Treatment Arm
10 Patients will receive treatment (Ranibizumab)
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Incidence and Severity of Ocular Adverse Event
时间窗: 16 Weeks
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
时间窗: 16 Weeks
次要结局
- Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs(Prospective)
- Efficacy by Measuring Mean Change of BCVA(Prospective)
研究者
Reza Dana, MD
Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary