Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- incidence and severity of ocular adverse events as identified by eye examination
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.
详细描述
Patients will be evaluated monthly for one year.
Participants will be assigned to one of two groups:
Group A will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study Group B will receive injections of ranibizumab on an as needed basis throughout the study
You cannot take part in this study if:
- You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
- You are under the age of 18
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 是
入选标准
- •age 18 or over
- •active choroidal neovascularization secondary to ocular histoplasmosis
- •Visual acuity between 20/25 and 20/400
排除标准
- •pregnancy or intent to become pregnant within the next 12 months
- •nursing an infant
- •premenopausal women not using contraception
- •prior treatment with subfoveal thermal laser
- •allergy to sodium fluorescein simultaneous participation in another investigation or trial
研究组 & 干预措施
Monthly injections
3 monthly injections of ranibizumab followed by prn injections
干预措施: ranibizumab (Drug)
PRN injections
injections of ranibizumab on a prn basis from the start of the study
干预措施: ranibizumab (Drug)
结局指标
主要结局
incidence and severity of ocular adverse events as identified by eye examination
时间窗: 1 year
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
时间窗: 12 mos
次要结局
- mean change in visual acuity(1 year)
- mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography(6 and 12 months)
- change in fluorescein angiographic outcomes(12 months)
- mean number of injections(12 mos)