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Retinal Artery OcclusionPhase 3EAGLENCT00637468

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

A Phase 3 study testing Intravenous injection of heparin, Intravenous injection of acetazolamide and Local intra-arterial fibrinolysis in people with Retinal Artery Occlusion and Fibrinolysis, run by University Hospital Freiburg at 21 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Intravenous injection of heparin, Intravenous injection of acetazolamide and Local intra-arterial fibrinolysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
21 sitesin 3 countries
Study dates
Sep 2002to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

Germany16 sites

  • Universityhospital of RWTH Aachen

    Aachen

  • Klinikum Augsburg

    Augsburg

  • Universityhospital Bonn

    Bonn

  • UKL Essen

    Essen

  • University Medical Center Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg

  • Allgemeines Krankenhaus Hamburg Altona

    Hamburg

  • UKE Hamburg

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Universityhospital Homburg/Saar

    Homburg/Saar

  • Universityhospital Kiel

    Kiel

  • Medizinische Universität zu Lübeck

    Lübeck

  • Universityhospital Magdeburg

    Magdeburg

  • Universityhospital Mainz

    Mainz

  • Universityhospital Marburg

    Marburg

  • LMU München

    München

  • Universityhospital Würzburg

    Würzburg

Other trials in Germany

Austria3 sites

  • Universityhospital Graz

    Graz

  • Universityhospital Innsbruck

    Innsbruck

  • Allgemeines Krankenhaus Wien

    Vienna

Other trials in Austria

Switzerland2 sites

  • Universitätsspital Bern

    Bern

  • Universitätsspital Zürich

    Zurich

Other trials in Switzerland

About this study

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

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.

Being tested
Intravenous injection of heparin, Intravenous injection of acetazolamide, Local intra-arterial fibrinolysis, Globe massage, Topical use of beta-blocker
Medical subject headings
Retinal Artery Occlusion, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous injection of heparinDrug

  • Intravenous injection of acetazolamideDrug

  • Local intra-arterial fibrinolysisProcedure or surgery

  • Globe massageProcedure or surgery

  • Topical use of beta-blockerDrug

  • Isovolaemic haemodilutionDrug

  • Acetylsalicylic acidDrug

Study groups in NCT00637468
Study groupRoleWhat they receive
1ExperimentalLocal intra-arterial fibrinolysis (LIF)
Receives: Drug: Intravenous injection of heparin; Procedure: Local intra-arterial fibrinolysis
2Active comparatorConservative standard therapy
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 month

Secondary outcomes (4)

  1. Improvement of visual field

    Measured: 1 month

  2. Effect on retinal circulation

    Measured: 1 month

  3. Tolerance of therapies and registration of number, form and severity of complications

    Measured: 1 month

  4. Evaluation of prognostic factors

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2008 (estimated)
  2. Study startSep 2002

Why it stopped: Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637468
Sponsor's protocol ID
S 020301
Acronym
EAGLE
Status last verified
Mar 2008
First submitted
11 Mar 2008
Last updated
18 Mar 2008
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 16372192

  • 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.

    PubMed 16998653

  • 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.

    PubMed 26349479

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous injection of heparin, Intravenous injection of acetazolamide and Local intra-arterial fibrinolysis in people with Retinal Artery Occlusion and Fibrinolysis, run by University Hospital Freiburg at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale. (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00637468, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2008; AzTrials last refreshed its copy on 6 Nov 2026.

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