Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
研究概览
简要总结
The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.
详细描述
Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks
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
- 是
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
- •Angioid streaks
- •Subfoveal CNV of recent onset with the following characteristics
- •Absence of subfoveal fibrosis
- •Fibrosis less than 25% of the lesion
- •Presence of blood, subretinal fluid, and/or lipid
- •New onset symptoms within 12 weeks
- •Visual acuity 20/40 to 20/800 on an ETDRS chart
排除标准
- •Prior treatment of subfoveal CNV in the study eye
- •Age-related macular degeneration
- •Uncontrolled glaucoma
- •High myopia (> -10.00 D spherical equivalent)
- •Prior retinal detachment
- •Media opacity preventing adequate view of the retina
- •Planned cataract surgery in the next 3 months
- •Current chemotherapy for cancer
- •Immunocompromised state
- •Pregnancy (positive pregnancy test) or lactation
- •Premenopausal women not using adequate contraception.
- •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
- •History of any previous treatment for angioid streaks
研究组 & 干预措施
ranibizumab
干预措施: ranibizumab (Drug)
结局指标
主要结局
The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
时间窗: Month 12
次要结局
- Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12(Month 6 and 12)
研究者
Jennifer I. Lim
Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences
University of Illinois at Chicago