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

Stroke Clinical Trial

— EAGLE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637468
• Other study ID #: S 020301
• Status: Terminated
• Phase: Phase 3
• First received: March 11, 2008
• Last updated: March 17, 2008
• Start date: September 2002

Study information

• Verified date: March 2008
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Intravenous injection of heparin

• Intravenous injection of acetazolamide

Procedure:
• Local intra-arterial fibrinolysis

• Globe massage

Drug:
• Topical use of beta-blocker

• Isovolaemic haemodilution

• Acetylsalicylic acid

Locations

Country	Name	City	State
Austria	Universityhospital Graz	Graz
Austria	Universityhospital Innsbruck	Innsbruck
Austria	Allgemeines Krankenhaus Wien	Wien
Germany	Universityhospital of RWTH Aachen	Aachen
Germany	Klinikum Augsburg	Augsburg
Germany	Universityhospital Bonn	Bonn
Germany	UKL Essen	Essen
Germany	University Medical Center Freiburg	Freiburg	Baden-Württemberg
Germany	Allgemeines Krankenhaus Hamburg Altona	Hamburg
Germany	UKE Hamburg	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
Switzerland	Universitätsspital Bern	Bern
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

References & Publications (2)

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. Epub 2005 Dec 22. — View Citation

Feltgen N, Reinhard T, Kampik A, Jurklies B, Brückmann 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. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale.		1 month	No
Secondary	Improvement of visual field		1 month	No
Secondary	Effect on retinal circulation		1 month	No
Secondary	Tolerance of therapies and registration of number, form and severity of complications		1 month	Yes
Secondary	Evaluation of prognostic factors			No