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

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Visual Acuity; Fibrinolysis; Retinal Artery Occlusion; Hemodilution
• Intervention / Treatment: Drug: Acetylsalicylic acid; Drug: Intravenous injection of heparin; Procedure: Local intra-arterial fibrinolysis; Drug: Intravenous injection of acetazolamide; Procedure: Globe massage; Drug: Topical use of beta-blocker; Drug: Isovolaemic haemodilution

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Universityhospital Graz
  • Innsbruck, Austria
    • Universityhospital Innsbruck
  • Wien, Austria
    • Allgemeines Krankenhaus Wien
• Germany
  • Aachen, Germany
    • Universityhospital of RWTH Aachen
  • Augsburg, Germany
    • Klinikum Augsburg
  • Bonn, Germany
    • Universityhospital Bonn
  • Essen, Germany
    • UKL Essen
  • Hamburg, Germany
    • UKE Hamburg
  • Hamburg, Germany
    • Allgemeines Krankenhaus Hamburg Altona
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Homburg/Saar, Germany
    • Universityhospital Homburg/Saar
  • Kiel, Germany
    • Universityhospital Kiel
  • Lübeck, Germany
    • Medizinische Universität zu Lübeck
  • Magdeburg, Germany
    • Universityhospital Magdeburg
  • Mainz, Germany
    • Universityhospital Mainz
  • Marburg, Germany
    • Universityhospital Marburg
  • München, Germany
    • LMU Munchen
  • Würzburg, Germany
    • Universityhospital Würzburg
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany
      • University Medical Center Freiburg
• Switzerland
  • Bern, Switzerland
    • Universitätsspital Bern
  • Zürich, Switzerland
    • Universitatsspital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Acetylsalicylic acid; Drug: Intravenous injection of heparin; Drug: Intravenous injection of acetazolamide; Procedure: Globe massage; Drug: Topical use of beta-blocker; Drug: Isovolaemic haemodilution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Martin Schumacher, Professor, Department of Neuroradiology, University Medical Center Freiburg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2002

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 17, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): March 18, 2008
• Last Update Submitted That Met QC Criteria: March 17, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Eye Diseases; Retinal Diseases; Retinal Artery Occlusion; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Anticoagulants; Aspirin; Acetazolamide; Heparin; Adrenergic beta-Antagonists
• Other Study ID Numbers: S 020301