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

• ClinicalTrials.gov Identifier: NCT00637468
• Recruitment Status: Terminated
• First Posted: March 18, 2008
• Last Update Posted: March 18, 2008
• Sponsor: University Hospital Freiburg
• Collaborator: Boehringer Ingelheim
• Information provided by: University Hospital Freiburg

Tracking Information

• First Submitted Date: March 11, 2008
• First Posted Date: March 18, 2008
• Last Update Posted Date: March 18, 2008
• Study Start Date: September 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 17, 2008): Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale. [ Time Frame: 1 month ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 17, 2008)

• Improvement of visual field [ Time Frame: 1 month ]
• Effect on retinal circulation [ Time Frame: 1 month ]
• Tolerance of therapies and registration of number, form and severity of complications [ Time Frame: 1 month ]
• Evaluation of prognostic factors

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• 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

Study Arms

• Experimental: 1
  Local intra-arterial fibrinolysis (LIF)
  Interventions:

  • Drug: Intravenous injection of heparin
  • Procedure: Local intra-arterial fibrinolysis
• Active Comparator: 2
  Conservative standard therapy
  Interventions:

  • 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

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 17, 2008): 84
• Original Actual Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Switzerland

Administrative Information

• NCT Number: NCT00637468
• Other Study ID Numbers: S 020301
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Freiburg
• Original Study Sponsor: Same as current
• Collaborators: Boehringer Ingelheim

Investigators

• Principal Investigator: Martin Schumacher, Professor; Department of Neuroradiology, University Medical Center Freiburg

• PRS Account: University Hospital Freiburg
• Verification Date: March 2008