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

This study has been terminated.
(Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.)
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00637468
First received: March 11, 2008
Last updated: March 17, 2008
Last verified: March 2008
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of visual field [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Effect on retinal circulation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Tolerance of therapies and registration of number, form and severity of complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Evaluation of prognostic factors [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: September 2002
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637468

Locations
Austria
Universityhospital Graz
Graz, Austria
Universityhospital Innsbruck
Innsbruck, Austria
Allgemeines Krankenhaus Wien
Wien, Austria
Germany
University Medical Center Freiburg
Freiburg, Baden-Württemberg, Germany
Universityhospital of RWTH Aachen
Aachen, Germany
Klinikum Augsburg
Augsburg, Germany
Universityhospital Bonn
Bonn, Germany
UKL Essen
Essen, Germany
UKE Hamburg
Hamburg, Germany
Allgemeines Krankenhaus Hamburg Altona
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, 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
Switzerland
Universitätsspital Bern
Bern, Switzerland
Universitätsspital Zürich
Zürich, Switzerland
Sponsors and Collaborators
University Hospital Freiburg
Boehringer Ingelheim
Investigators
Principal Investigator: Martin Schumacher, Professor Department of Neuroradiology, University Medical Center Freiburg
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00637468     History of Changes
Other Study ID Numbers: S 020301
Study First Received: March 11, 2008
Last Updated: March 17, 2008
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Retinal Artery Occlusion
Retinal Diseases
Eye Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Acetazolamide
Adrenergic beta-Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Adrenergic Antagonists

ClinicalTrials.gov processed this record on September 29, 2014