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

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ClinicalTrials.gov Identifier: NCT00637468
Recruitment Status : Terminated (Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.)
First Posted : March 18, 2008
Last Update Posted : March 18, 2008
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
University Hospital Freiburg

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retinal Artery Occlusion Fibrinolysis Visual Acuity Stroke Hemodilution 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 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multizenterstudie Der European Assessment Group for Lysis in the Eye (EAGLE) Zur Behandlung Des Zentralarterienverschlusses (ZAV): Lysetherapie Versus Konservative Therapie
Study Start Date : September 2002
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Local intra-arterial fibrinolysis (LIF)
 Drug: Intravenous injection of heparin
Procedure: Local intra-arterial fibrinolysis
Active Comparator: 2
Conservative standard therapy
 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


Outcome Measures
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Primary Outcome Measures :
  1. Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Improvement of visual field [ Time Frame: 1 month ]
  2. Effect on retinal circulation [ Time Frame: 1 month ]
  3. Tolerance of therapies and registration of number, form and severity of complications [ Time Frame: 1 month ]
  4. Evaluation of prognostic factors

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637468


Locations
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Sponsors and Collaborators
University Hospital Freiburg
Boehringer Ingelheim
Investigators
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Principal Investigator: Martin Schumacher, Professor Department of Neuroradiology, University Medical Center Freiburg
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00637468    
Other Study ID Numbers: S 020301
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: March 18, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Retinal Artery Occlusion
Retinal Diseases
Eye Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Heparin
Acetazolamide
Adrenergic beta-Antagonists
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics
Natriuretic Agents