Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 1:14 AM
Study NCT ID:
NCT00637468
Status:
TERMINATED
Last Update Posted:
2008-03-18
First Post:
2008-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015356', 'term': 'Retinal Artery Occlusion'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-17', 'studyFirstSubmitDate': '2008-03-11', 'studyFirstSubmitQcDate': '2008-03-17', 'lastUpdatePostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale.', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Improvement of visual field', 'timeFrame': '1 month'}, {'measure': 'Effect on retinal circulation', 'timeFrame': '1 month'}, {'measure': 'Tolerance of therapies and registration of number, form and severity of complications', 'timeFrame': '1 month'}, {'measure': 'Evaluation of prognostic factors'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Retinal Artery Occlusion', 'Fibrinolysis', 'Visual Acuity', 'Stroke', 'Hemodilution']}, 'referencesModule': {'references': [{'pmid': '16372192', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16998653', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26349479', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subtotal central retinal artery occlusion or central retinal artery occlusion with choroidal hypoperfusion not lasting longer than 20h\n* Patients aged from 18 years to 75 years (in case of pre-existing blindness of other eye also older than 75 years)\n* Informed consent of the patient\n\nExclusion Criteria:\n\n* Central retinal artery occlusion lasting longer than 20h\n* 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)\n* 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\n* 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\n* Patient participation in other studies during the prior 4 weeks\n* No willingness and ability of the patient to participate in all follow-up examinations\n* Pregnancy\n* Written consent not given\n* Patient is not mobile (bedridden)\n* Other conditions/ circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, no fixed abode)'}, 'identificationModule': {'nctId': 'NCT00637468', 'acronym': 'EAGLE', 'briefTitle': 'EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Multizenterstudie Der European Assessment Group for Lysis in the Eye (EAGLE) Zur Behandlung Des Zentralarterienverschlusses (ZAV): Lysetherapie Versus Konservative Therapie', 'orgStudyIdInfo': {'id': 'S 020301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Local intra-arterial fibrinolysis (LIF)', 'interventionNames': ['Drug: Intravenous injection of heparin', 'Procedure: Local intra-arterial fibrinolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Conservative standard therapy', 'interventionNames': ['Drug: Intravenous injection of heparin', 'Drug: Intravenous injection of acetazolamide', 'Procedure: Globe massage', 'Drug: Topical use of beta-blocker', 'Drug: Isovolaemic haemodilution', 'Drug: Acetylsalicylic acid']}], 'interventions': [{'name': 'Intravenous injection of heparin', 'type': 'DRUG', 'armGroupLabels': ['1', '2']}, {'name': 'Intravenous injection of acetazolamide', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Local intra-arterial fibrinolysis', 'type': 'PROCEDURE', 'armGroupLabels': ['1']}, {'name': 'Globe massage', 'type': 'PROCEDURE', 'armGroupLabels': ['2']}, {'name': 'Topical use of beta-blocker', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Isovolaemic haemodilution', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Acetylsalicylic acid', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Universityhospital Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universityhospital Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Medical Center Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'Universityhospital of RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'Klinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Universityhospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'UKL Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Allgemeines Krankenhaus Hamburg Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'UKE Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Universityhospital Homburg/Saar'}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universityhospital Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Medizinische Universität zu Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universityhospital Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Universityhospital Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Universityhospital Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'München', 'country': 'Germany', 'facility': 'LMU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universityhospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Martin Schumacher, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neuroradiology, University Medical Center Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}]}}}