Pilot Study on Efficacy and Tolerance of Intravitreous Injection of Ranibizumab (Lucentis®) in Early-onset Central Retinal Vein Occlusion in Comparison to Hemodilution Using Erythrocytapheresis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in visual acuity
研究概览
简要总结
The purpose of this study is to compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect.
详细描述
Patients with recent-onset CRVO (lasting for less than 1 month)are randomly assigned to one of 3 groups: hemodilution using erythrocytapheresis alone, 3 monthly injection of ranibizumab alone, or both.
Patients are followed monthly during the 6-month study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRVO confirmed by fluorescein angiography
- •duration from onset of 1 month or less
- •visual acuity of 20/32 or less
排除标准
- •neovascular complication
- •extensive retinal ischemia requiring prompt panretinal photocoagulation
- •hematocrit level lower than 38%
- •previous laser or surgery in the study eye, etc
研究组 & 干预措施
ranibizumab
patients in this arm receive 3 monthly injection of ranibizumab
干预措施: ranibizumab (Drug)
Hemodilution
hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
干预措施: hemodilution (Procedure)
ranibizumab and hemodilution
patients receive both treatments
干预措施: ranibizumab (Drug)
ranibizumab and hemodilution
patients receive both treatments
干预措施: hemodilution (Procedure)
结局指标
主要结局
Change in visual acuity
时间窗: 6 months
Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months
次要结局
- Gain in visual acuity of 2 ETDRS-lines or more(6 months)
研究者
Agnes Glacet-Bernard
Principal Investigator
Centre Hospitalier Intercommunal Creteil