Multizenterstudie Der European Assessment Group for Lysis in the Eye (EAGLE) Zur Behandlung Des Zentralarterienverschlusses (ZAV): Lysetherapie Versus Konservative Therapie
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 84
- 试验地点
- 21
- 主要终点
- Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale.
研究概览
简要总结
The aim of the EAGLE Study is to compare the efficacy of conservative medical treatment and local intraarterial fibrinolysis in patients with central retinal artery occlusion and to evaluate benefit and risk for the patient of both therapies.
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
- •Subtotal central retinal artery occlusion or central retinal artery occlusion with choroidal hypoperfusion not lasting longer than 20h
- •Patients aged from 18 years to 75 years (in case of pre-existing blindness of other eye also older than 75 years)
- •Informed consent of the patient
排除标准
- •Central retinal artery occlusion lasting longer than 20h
- •Eye diseases, namely branch retinal artery occlusion, cilioretinal arteries supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy and elevated intraocular pressure (over 30 mmHg)
- •Systemic diseases, namely severe general diseases, systemic arterial hypertension (systolic pressure > 200 mmHg), despite medical therapy, acute systemic inflammation (erythrocyte sedimentation rate > 30 mm within the first hour/ C-reactive protein > 1,0 mg/dl), antithrombin-III deficiency in case of thrombocytopenia (< 100000 per ml): pathologic clotting time, acute pancreatitis with elevated pancreas enzymes
- •Medical History: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with marcumar/warfarin, allergic reaction to contrast agent, haemorrhagic diathesis, aneurysms, inflammatory vascular diseases (e.g., giant cell arteritis, Wegener´s granulomatosis), endocarditis, gastric ulcer
- •Patient participation in other studies during the prior 4 weeks
- •No willingness and ability of the patient to participate in all follow-up examinations
- •Pregnancy
- •Written consent not given
- •Patient is not mobile (bedridden)
- •Other conditions/ circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, no fixed abode)
研究组 & 干预措施
1
Local intra-arterial fibrinolysis (LIF)
干预措施: Intravenous injection of heparin (Drug)
1
Local intra-arterial fibrinolysis (LIF)
干预措施: Local intra-arterial fibrinolysis (Procedure)
2
Conservative standard therapy
干预措施: Intravenous injection of heparin (Drug)
2
Conservative standard therapy
干预措施: Intravenous injection of acetazolamide (Drug)
2
Conservative standard therapy
干预措施: Globe massage (Procedure)
2
Conservative standard therapy
干预措施: Topical use of beta-blocker (Drug)
2
Conservative standard therapy
干预措施: Isovolaemic haemodilution (Drug)
2
Conservative standard therapy
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale.
时间窗: 1 month
次要结局
- Effect on retinal circulation(1 month)
- Improvement of visual field(1 month)
- Tolerance of therapies and registration of number, form and severity of complications(1 month)
- Evaluation of prognostic factors