Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

NCT ID: NCT01581411

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-11-30

Brief Summary

Central retinal vein occlusion (CRVO) is a common cause of vision loss, typically affecting individuals during the fifth through seventh decade of life. Eyes with severe CRVO have a poor visual prognosis because current treatments address only secondary complications of CRVO without treating its cause. Intra-ophthalmic artery injection of a small dose of t-PA (clot busting medicine), also called intra-ophthalmic artery thrombolysis, may reopen the central retinal vein-and address the cause of the disease- without exposing the subject to the risks of systemic thrombolysis. Our project aims to evaluate the safety and efficacy of intra-ophthalmic artery thrombolysis in subjects with CRVO.

Detailed Description

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.

Conditions

Central Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IA t-PA

intra-ophthalmic artery injection of tissue plasminogen activator

Group Type: EXPERIMENTAL

Tissue Plasminogen Activator

Intervention Type: DRUG

Intra-ophthalmic artery injection of 2 mg t-PA over 10 minutes followed by 10 mg t-PA over 2 hours

Interventions

Tissue Plasminogen Activator

Intra-ophthalmic artery injection of 2 mg t-PA over 10 minutes followed by 10 mg t-PA over 2 hours

Intervention Type: DRUG

Other Intervention Names

intra-arterial thrombolysis

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Y Pierre Gobin, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College/ New York Presbyterian hospital

New York, New York, United States

Countries

United States

Other Identifiers

CRVO-IAT1

Identifier Type: -

Identifier Source: org_study_id