Clinical trial NCT00637468: EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Retinal Artery Occlusion
Fibrinolysis
Visual Acuity
Stroke
Hemodilution
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2008-03-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale.
timeFrame: 1 month
Secondary outcomes:
measure: Improvement of visual field
timeFrame: 1 month
measure: Effect on retinal circulation
timeFrame: 1 month
measure: Tolerance of therapies and registration of number, form and severity of complications
timeFrame: 1 month
measure: Evaluation of prognostic factors
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universityhospital Graz
city: Innsbruck
country: Austria
facility: Universityhospital Innsbruck
city: Wien
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
state: Baden-Württemberg
city: Aachen
country: Germany
facility: Universityhospital of RWTH Aachen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bonn
country: Germany
facility: Universityhospital Bonn
city: Essen
country: Germany
facility: UKL Essen
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Hamburg Altona
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg/Saar
country: Germany
facility: Universityhospital Homburg/Saar
city: Kiel
country: Germany
facility: Universityhospital Kiel
city: Lübeck
country: Germany
facility: Medizinische Universität zu Lübeck
city: Magdeburg
country: Germany
facility: Universityhospital Magdeburg
city: Mainz
country: Germany
facility: Universityhospital Mainz
city: Marburg
country: Germany
facility: Universityhospital Marburg
city: München
country: Germany
facility: LMU München
city: Würzburg
country: Germany
facility: Universityhospital Würzburg
city: Bern
country: Switzerland
facility: Universitätsspital Bern
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Department of Neuroradiology, University Medical Center Freiburg
name: Martin Schumacher, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.