Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).
详细描述
Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a special entity in AMD. As yet, no standard treatment has been established for this disease.The stimuli that induce PED are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (VEGF) also play a role in the pathogenesis. Ranibizumab is an anti-VEGF antibody fragment that blocks VEGF activity in patients with neovascular AMD.
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
- •patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (OCT)
- •patients who have a best-corrected visual acuity (BCVA) score between 73 and 24 ETDRS letters
- •patients with pigment epithelial detachment (PED) ≥ 200 µm as determined by OCT
- •male or female patients 50 years of age or greater
- •patients willing and able to comply with all study procedures
排除标准
- •patients with best-corrected visual acuity (BCVA) < 24 or >73 letters in the study eye
- •patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation
- •history of uncontrolled glaucoma in the study eye
研究组 & 干预措施
1 Arm Ranibizumab
干预措施: intravitreal injection with ranibizumab (Drug)
结局指标
主要结局
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
时间窗: 12 months
次要结局
- Mean change in best corrected visual acuity(12 months)
- Central visual field and stability of fixation(12 months)
- Fluorescein leakage and changes in autofluorescence(12 months)
- Safety(12 months)
- Change in retinal thickness and height of pigment epithelial detachment(12 months)
研究者
Nicole Eter
Director of Ophthalmology Department
University Hospital Muenster