Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01581411
Recruitment Status : Unknown
Verified April 2012 by Pierre Gobin, Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
First Posted : April 20, 2012
Last Update Posted : April 20, 2012
Information provided by (Responsible Party):
Pierre Gobin, Weill Medical College of Cornell University

Brief Summary:
  1. Study hypothesis: Injection of t-PA, a thrombolytic drug (clot busting medicine)into the ophthalmic artery (the blood vessel feeding the eye), in patients with recent severe central retinal vein occlusion, may reopen the central retinal vein and improve retinal blood flow, which may in turn improve visual acuity and prevent the long-term complications of the disease.
  2. Experimental intervention: An outpatient procedure during which the ophthalmic artery is selective catheterized (with a small plastic tube called a microcatheter introduced from the artery of the leg) and infused with t-PA during two hours.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: Tissue Plasminogen Activator Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Intra-Ophthalmic Artery Thrombolysis for Treating Recent Severe Central Retinal Vein Occlusion
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IA t-PA
intra-ophthalmic artery injection of tissue plasminogen activator
Drug: Tissue Plasminogen Activator
Intra-ophthalmic artery injection of 2 mg t-PA over 10 minutes followed by 10 mg t-PA over 2 hours
Other Name: intra-arterial thrombolysis

Primary Outcome Measures :
  1. Improvement of retinal perfusion on the 1-week fluorescein angiogram, with no severe complications. [ Time Frame: One week ]

Secondary Outcome Measures :
  1. Number of patients with 3 or more lines of visual acuity improvement during follow up. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Severe CRVO diagnosed on

    • presence of relative afferent papillary defect (RAPD)
    • or visual acuity of 20/200 or worse
  • Symptom onset within 2 weeks
  • Age > 18 years old
  • Patient is able and willing to give informed consent

Exclusion Criteria:

  • Futile intervention: no light perception, absence of perfusion on fluorescein angiography.
  • Contra-indication to thrombolysis: active or recent (1 month) internal bleeding, cerebrovascular accident, major organ surgery, major trauma; intracranial neoplasm or vascular malformation, known bleeding diathesis, severe uncontrolled arterial hypertension, pregnancy (women of childbearing age must have a negative serum pregnancy test), or any other condition which in the opinion of the investigators would preclude the use of thrombolytic agents.
  • High-risk catheterization: history of stroke or TIA; carotid bruit or known carotid occlusive disease; any cardiovascular condition that in the opinion of the investigators may increase the risk of catheterization of the ophthalmic artery.
  • Ocular criteria: Intraocular neovascularization (secondary to any etiology), vitreous hemorrhage, inflammatory eye disease, any condition that precludes fundus photography or fluorescein angiography.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581411

Contact: Y Pierre Gobin, MD 212 746 4998
Contact: Kimberly Salvaggio, NP 212 746 4998

United States, New York
Weill Cornell Medical College/ New York Presbyterian hospital Recruiting
New York, New York, United States, 10065
Contact: Y Pierre Gobin, MD    212-746-4998   
Contact: Kimberly Salvaggio, NP    212 746 4998   
Principal Investigator: Y Pierre Gobin, MD         
Sub-Investigator: Szilard Kiss, MD         
Sub-Investigator: Athos Patsalides, MD         
Sub-Investigator: Donald D'Amico, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University

Responsible Party: Pierre Gobin, Professor of Radiology in Neurosurgery and Neurology, Weill Medical College of Cornell University Identifier: NCT01581411     History of Changes
Other Study ID Numbers: CRVO-IAT1
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012

Keywords provided by Pierre Gobin, Weill Medical College of Cornell University:
central retinal vein occlusion
macular edema
vision loss
rtelative afferent papillary defect

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action