NCT01914159已完成2 期
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
University Hospital, Bonn3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Best-corrected Visual Acuity
研究概览
简要总结
The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
- •Written informed consent
排除标准
- •Time of diagnosis more than 6 months before study recruitment
- •Ocular surgery of the study eye within 1 month before study recruitment
- •Extensive subretinal fibrosis or retinal atrophy of the study eye
- •Significant opacification of optical media of the study eye
- •Uncontrolled glaucoma of the study eye
- •Active ocular inflammation of the study eye
- •Best-corrected visual acuity of the contralateral eye below 20/200
- •Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs
研究组 & 干预措施
Ranibizumab
Experimental
干预措施: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany) (Drug)
结局指标
主要结局
Best-corrected Visual Acuity
时间窗: 12 months
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
次要结局
- Vision-related Quality of Life(12 months)
- Retinal Morphology(12 months)
研究者
Frank G. Holz
Director, Department of Ophthalmology, University of Bonn
University Hospital, Bonn
研究点 (3)
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