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

Study Overview
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Brief Summary
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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.

Official Title
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Multizenterstudie Der European Assessment Group for Lysis in the Eye (EAGLE) Zur Behandlung Des Zentralarterienverschlusses (ZAV): Lysetherapie Versus Konservative Therapie

Conditions
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Retinal Artery Occlusion, Fibrinolysis, Visual Acuity, Stroke, Hemodilution

Intervention / Treatment
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* Drug: Intravenous injection of heparin
* Drug: Intravenous injection of acetazolamide
* Procedure: Local intra-arterial fibrinolysis
* Procedure: Globe massage
* Drug: Topical use of beta-blocker
* Drug: Isovolaemic haemodilution
* Drug: Acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Local intra-arterial fibrinolysis (LIF) | Drug: Intravenous injection of heparin<br> <br> Procedure: Local intra-arterial fibrinolysis<br> <br> |
| Active Comparator: 2<br>Conservative standard therapy | Drug: Intravenous injection of heparin<br> <br> Drug: Intravenous injection of acetazolamide<br> <br> Procedure: Globe massage<br> <br> Drug: Topical use of beta-blocker<br> <br> Drug: Isovolaemic haemodilution<br> <br> Drug: Acetylsalicylic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of visual field |  | 1 month | 
| Effect on retinal circulation |  | 1 month | 
| Tolerance of therapies and registration of number, form and severity of complications |  | 1 month | 
| Evaluation of prognostic factors |  |  |