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

NCT00637468 | Terminated Phase 3 DMC

• 1 other identifier: S 020301
• Study Type: interventional
• Target: 84
• Locations: 3 countries
• Sites: 21

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.

Conditions

Retinal Artery Occlusion; Fibrinolysis; Visual Acuity; Stroke; Hemodilution

Outcome Measures

Primary Outcomes (1)

• Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale.

  1 month

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Local intra-arterial fibrinolysis (LIF)

Drug: Intravenous injection of heparin; Procedure: Local intra-arterial fibrinolysis

2

ACTIVE COMPARATOR

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

Interventions

Intravenous injection of heparin DRUG

1; 2

Intravenous injection of acetazolamide DRUG

2

Local intra-arterial fibrinolysis PROCEDURE

1

Globe massage PROCEDURE

2

Topical use of beta-blocker DRUG

2

Isovolaemic haemodilution DRUG

2

Acetylsalicylic acid DRUG

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Boehringer Ingelheim: collaborator

Study Sites (21)

Universityhospital Graz

Graz, Austria

Location

Universityhospital Innsbruck

Innsbruck, Austria

Location

Allgemeines Krankenhaus Wien

Vienna, Austria

Location

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Location

Universityhospital of RWTH Aachen

Aachen, Germany

Location

Klinikum Augsburg

Augsburg, Germany

Location

Universityhospital Bonn

Bonn, Germany

Location

UKL Essen

Essen, Germany

Location

Allgemeines Krankenhaus Hamburg Altona

Hamburg, Germany

Location

UKE Hamburg

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universityhospital Homburg/Saar

Homburg/Saar, Germany

Location

Universityhospital Kiel

Kiel, Germany

Location

Medizinische Universität zu Lübeck

Lübeck, Germany

Location

Universityhospital Magdeburg

Magdeburg, Germany

Location

Universityhospital Mainz

Mainz, Germany

Location

Universityhospital Marburg

Marburg, Germany

Location

LMU München

München, Germany

Location

Universityhospital Würzburg

Würzburg, Germany

Location

Universitätsspital Bern

Bern, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

Related Publications (3)

• 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: 16372192 BACKGROUND

• 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: 16998653 BACKGROUND

• 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.

  PMID: 26349479 DERIVED

MeSH Terms

Conditions

Retinal Artery Occlusion; Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Martin Schumacher, Professor

  Department of Neuroradiology, University Medical Center Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: September 1, 2002
• Last Updated: March 18, 2008

Record last verified: 2008-03

Locations

AU (3); DE (16); CH (2)