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

Sponsor

University Hospital Freiburg (Other)

Overall Status

Terminated

CT.gov ID

NCT00637468

Collaborator

Boehringer Ingelheim (Industry)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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

Study Type:

Interventional

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 :

Sep 1, 2002

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Universityhospital Graz	Graz		Austria
2	Universityhospital Innsbruck	Innsbruck		Austria
3	Allgemeines Krankenhaus Wien	Wien		Austria
4	University Medical Center Freiburg	Freiburg	Baden-Württemberg	Germany
5	Universityhospital of RWTH Aachen	Aachen		Germany
6	Klinikum Augsburg	Augsburg		Germany
7	Universityhospital Bonn	Bonn		Germany
8	UKL Essen	Essen		Germany
9	Allgemeines Krankenhaus Hamburg Altona	Hamburg		Germany
10	UKE Hamburg	Hamburg		Germany
11	Medizinische Hochschule Hannover	Hannover		Germany
12	Universityhospital Homburg/Saar	Homburg/Saar		Germany
13	Universityhospital Kiel	Kiel		Germany
14	Medizinische Universität zu Lübeck	Lübeck		Germany
15	Universityhospital Magdeburg	Magdeburg		Germany
16	Universityhospital Mainz	Mainz		Germany
17	Universityhospital Marburg	Marburg		Germany
18	LMU München	München		Germany
19	Universityhospital Würzburg	Würzburg		Germany
20	Universitätsspital Bern	Bern		Switzerland
21	Universitätsspital Zürich	Zürich		Switzerland