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

Primary Purpose

Retinal Artery Occlusion, Fibrinolysis, Visual Acuity

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Intravenous injection of heparin
Intravenous injection of acetazolamide
Local intra-arterial fibrinolysis
Globe massage
Topical use of beta-blocker
Isovolaemic haemodilution
Acetylsalicylic acid
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Artery Occlusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Local intra-arterial fibrinolysis (LIF)

Conservative standard therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement of visual field
Effect on retinal circulation
Tolerance of therapies and registration of number, form and severity of complications
Evaluation of prognostic factors

Full Information

First Posted
March 11, 2008
Last Updated
March 17, 2008
Sponsor
University Hospital Freiburg
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00637468
Brief Title
EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye
Acronym
EAGLE
Official Title
Multizenterstudie Der European Assessment Group for Lysis in the Eye (EAGLE) Zur Behandlung Des Zentralarterienverschlusses (ZAV): Lysetherapie Versus Konservative Therapie
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Freiburg
Collaborators
Boehringer Ingelheim

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Artery Occlusion, Fibrinolysis, Visual Acuity, Stroke, Hemodilution

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Local intra-arterial fibrinolysis (LIF)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conservative standard therapy
Intervention Type
Drug
Intervention Name(s)
Intravenous injection of heparin
Intervention Type
Drug
Intervention Name(s)
Intravenous injection of acetazolamide
Intervention Type
Procedure
Intervention Name(s)
Local intra-arterial fibrinolysis
Intervention Type
Procedure
Intervention Name(s)
Globe massage
Intervention Type
Drug
Intervention Name(s)
Topical use of beta-blocker
Intervention Type
Drug
Intervention Name(s)
Isovolaemic haemodilution
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Primary Outcome Measure Information:
Title
Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Improvement of visual field
Time Frame
1 month
Title
Effect on retinal circulation
Time Frame
1 month
Title
Tolerance of therapies and registration of number, form and severity of complications
Time Frame
1 month
Title
Evaluation of prognostic factors

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schumacher, Professor
Organizational Affiliation
Department of Neuroradiology, University Medical Center Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universityhospital Graz
City
Graz
Country
Austria
Facility Name
Universityhospital Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Allgemeines Krankenhaus Wien
City
Wien
Country
Austria
Facility Name
University Medical Center Freiburg
City
Freiburg
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Universityhospital of RWTH Aachen
City
Aachen
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Universityhospital Bonn
City
Bonn
Country
Germany
Facility Name
UKL Essen
City
Essen
Country
Germany
Facility Name
Allgemeines Krankenhaus Hamburg Altona
City
Hamburg
Country
Germany
Facility Name
UKE Hamburg
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universityhospital Homburg/Saar
City
Homburg/Saar
Country
Germany
Facility Name
Universityhospital Kiel
City
Kiel
Country
Germany
Facility Name
Medizinische Universität zu Lübeck
City
Lübeck
Country
Germany
Facility Name
Universityhospital Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Universityhospital Mainz
City
Mainz
Country
Germany
Facility Name
Universityhospital Marburg
City
Marburg
Country
Germany
Facility Name
LMU München
City
München
Country
Germany
Facility Name
Universityhospital Würzburg
City
Würzburg
Country
Germany
Facility Name
Universitätsspital Bern
City
Bern
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16372192
Citation
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.
Results Reference
background
PubMed Identifier
16998653
Citation
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.
Results Reference
background
PubMed Identifier
26349479
Citation
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.
Results Reference
derived

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

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