Multicenter trial of the European Assessment Group for Lysis in the Eye (EAGLE) : Therapy of the Central retinal artery occlusion: Lysis versus conservative treatment

Phase 3

• Conditions: H34.1; Central retinal artery occlusion

• Registration Number: DRKS00000088
• Lead Sponsor: niversitätsklinikum Freiburg Neuroradiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

patients between 18 and 75 years old
- central retinal artery occlusion within the last 20 h, leading to blindness or a visual acuity < 0,32
- informed written consent
- lack of existing exclusion criteria

Exclusion Criteria

- central retinal artery occlusion lasting longer than 20 h
- branch retinal artery occlusion
- cilioretinal artery supplying the macula (fundoscopy)
- severe proliferative diabetic retinopathy (fundoscopy)
- elevated intraocular pressure > 30 mmHg
- not treatable systemic arterial hypertension (non-resposive to acute therapy of Hypertension with persisting systolic pressure >= 200 mmHg
- acute systemic inflammation
- amtithrombin III deficiency
- acute pancreatitis with pathological elevated pancreas enzymes
- liver cirrhosis
- pregnancy
- incapability of contracting
more than 3 retinal bleedings
- thrombocytopenia < 100000/µl
- myocardial infarction within the last 6 weeks
- bleeding, cerebral stroke or surgery within the last 4 weeks
- marcumar therapy
- haemorrhagic diathesis
- allergic to contrast agent
- sensitization against fluorescein
- known aneurysms
- known inflammatory vascualr diseases
- known endocarditis
- known gastric ulcers
- bedridden
- patients participation on other trials within the last 4 weeks

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of visual acuity, measured according to ETDRS. Assessment by measurement before and 1 month after treatment.

Secondary Outcome Measures

Name	Time	Method
1. Treatment effect on visual field improvement.<br>2. Treatment effect on retinal circulation<br>3. Treatment tolerance and ascertainment of number, form and severity of complications.<br>4. Evaluation of prognostic factors:<br>- start of treatment<br>- severity of central retinal artery occlusion<br>- coincidental underlying diseases (Carotis stenosis, arterial hypertension, diabetes, arteriosclerosis