EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye

University Hospital Freiburg

Status and phase: Terminated; Phase 3

Conditions: Hemodilution; Fibrinolysis; Retinal Artery Occlusion; Stroke; Visual Acuity

Treatments: Drug: Isovolaemic haemodilution; Drug: Acetylsalicylic acid; Drug: Intravenous injection of heparin; Drug: Intravenous injection of acetazolamide; Procedure: Local intra-arterial fibrinolysis; Drug: Topical use of beta-blocker; Procedure: Globe massage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00637468

S 020301

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

1

Experimental group

Description:

Local intra-arterial fibrinolysis (LIF)

Treatment:

Procedure: Local intra-arterial fibrinolysis

Drug: Intravenous injection of heparin

2

Active Comparator group

Description:

Conservative standard therapy

Treatment:

Drug: Acetylsalicylic acid

Drug: Topical use of beta-blocker

Procedure: Globe massage

Drug: Isovolaemic haemodilution

Drug: Intravenous injection of heparin

Drug: Intravenous injection of acetazolamide