Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Pierre Gobin, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01581411
First received: April 12, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose
  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 Intervention Phase
Central Retinal Vein Occlusion
Drug: Tissue Plasminogen Activator
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Intra-Ophthalmic Artery Thrombolysis for Treating Recent Severe Central Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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

Secondary Outcome Measures:
  • Number of patients with 3 or more lines of visual acuity improvement during follow up. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581411

Contacts
Contact: Y Pierre Gobin, MD 212 746 4998 yvg2001@med.cornell.edu
Contact: Kimberly Salvaggio, NP 212 746 4998 kas2004@med.cornell.edu

Locations
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    yvg2001@med.cornell.edu   
Contact: Kimberly Salvaggio, NP    212 746 4998    kas2004@med.cornell.edu   
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
  More Information

Additional Information:
No publications provided

Responsible Party: Pierre Gobin, Professor of Radiology in Neurosurgery and Neurology, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01581411     History of Changes
Other Study ID Numbers: CRVO-IAT1
Study First Received: April 12, 2012
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis
Plasminogen
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014