Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- retinal capillary non-perfusion
研究概览
简要总结
The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine
详细描述
introduction
The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine.
Hypothesis
Hydroxycarbamide (HC) by reducing the erythrocyte adhesion to the endothelium may prevent or delay the onset of retinal capillary non-perfusion in patients with CRVO.
Primary objective: To assess the efficacy at 3 months of treatment with HC on retinal capillary perfusion in patients with a recent CRVO.
Secondary Objectives: To evaluate the safety of the treatment, the efficacy to 6 months on retinal perfusion of the treatment with HC (HC peak effect on the red cell adhesion in vitro), and the biological effects of HC, in particular on adhesion to endothelium and erythrocyte hemorheological parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes of at least 45 years of age.
- •with social protection
- •Presenting CRVO for less than 1 month duration
- •With a decrease of visual acuity and with the best corrected visual acuity lower than 6/10 (73 ETDRS letters)
- •Signature of informed consent
排除标准
- •predictable lack of compliance to the protocol
- •monophtalmic patient or any ocular history or condition that could interfere with the study course or results interpretation.
- •active systemic disease
- •sickle cell disease
- •myeloproliferative disease
- •myelosuppression
- •kidney or liver insufficiency
- •ongoing treatment with hydroxycarbamide or anticoagulant
- •Pregnancy, breast-feeding, no efficient contraception (for both sexes)
- •wish of paternity (for males of al least 45 years of age)
结局指标
主要结局
retinal capillary non-perfusion
时间窗: 3 months
To assess the percentage of subjects in whom one of the following events will not be observed at W13 (any event being considered as one of the criteria of worsening of retinal capillary non-perfusion): * Occurence of at least one direct sign of retinal ischemia: Increase of more than 30% of peripheral retinal non-perfusion on large-field angiography or of the central avascular zone of the retina, * Occurence of at least one indirect sign of retinal ischemia: reperfusion of the aterial iris circle, rubeosis iridis, neovascular glaucoma or abolition of the afferent pupillary reflex.
次要结局
- retinal capillary non-perfusion(2 weeks, 2 months and 6 months)
- Hydroxycarbamide safety - visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.(2 weks, 2 months, 3 months and 6 months)