EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye
NCT ID: NCT00637468
Last Updated: 2008-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
84 participants
INTERVENTIONAL
2002-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Local intra-arterial fibrinolysis (LIF)
Intravenous injection of heparin
Local intra-arterial fibrinolysis
2
Conservative standard therapy
Intravenous injection of heparin
Intravenous injection of acetazolamide
Globe massage
Topical use of beta-blocker
Isovolaemic haemodilution
Acetylsalicylic acid
Interventions
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Intravenous injection of heparin
Intravenous injection of acetazolamide
Local intra-arterial fibrinolysis
Globe massage
Topical use of beta-blocker
Isovolaemic haemodilution
Acetylsalicylic acid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
University Hospital Freiburg
OTHER
Principal Investigators
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Martin Schumacher, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Neuroradiology, University Medical Center Freiburg
Locations
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Universityhospital Graz
Graz, , Austria
Universityhospital Innsbruck
Innsbruck, , Austria
Allgemeines Krankenhaus Wien
Vienna, , Austria
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universityhospital of RWTH Aachen
Aachen, , Germany
Klinikum Augsburg
Augsburg, , Germany
Universityhospital Bonn
Bonn, , Germany
UKL Essen
Essen, , Germany
Allgemeines Krankenhaus Hamburg Altona
Hamburg, , Germany
UKE Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universityhospital Homburg/Saar
Homburg/Saar, , Germany
Universityhospital Kiel
Kiel, , Germany
Medizinische Universität zu Lübeck
Lübeck, , Germany
Universityhospital Magdeburg
Magdeburg, , Germany
Universityhospital Mainz
Mainz, , Germany
Universityhospital Marburg
Marburg, , Germany
LMU München
München, , Germany
Universityhospital Würzburg
Würzburg, , Germany
Universitätsspital Bern
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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References
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Feltgen N, Neubauer A, Jurklies B, Schmoor C, Schmidt D, Wanke J, Maier-Lenz H, Schumacher M; EAGLE-Study Group. Multicenter study of the European Assessment Group for Lysis in the Eye (EAGLE) for the treatment of central retinal artery occlusion: design issues and implications. EAGLE Study report no. 1 : EAGLE Study report no. 1. Graefes Arch Clin Exp Ophthalmol. 2006 Aug;244(8):950-6. doi: 10.1007/s00417-005-0140-2. Epub 2005 Dec 22.
Feltgen N, Reinhard T, Kampik A, Jurklies B, Bruckmann H, Schumacher M. [Lysis therapy vs. conservative therapy: randomised and prospective study on the treatment of acute central retinal artery occlusion (EAGLE study)]. Ophthalmologe. 2006 Oct;103(10):898-900. doi: 10.1007/s00347-006-1429-1. German.
Pielen A, Pantenburg S, Schmoor C, Schumacher M, Feltgen N, Junker B, Callizo J; EAGLE Study Group. Predictors of prognosis and treatment outcome in central retinal artery occlusion: local intra-arterial fibrinolysis vs. conservative treatment. Neuroradiology. 2015 Oct;57(10):1055-62. doi: 10.1007/s00234-015-1588-3. Epub 2015 Sep 8.
Other Identifiers
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S 020301
Identifier Type: -
Identifier Source: org_study_id