Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

Phase 1 Trial of Intra-Ophthalmic Artery Thrombolysis for Treating Recent Severe Central Retinal Vein Occlusion

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.

Study Overview

• Status: Completed
• Conditions: Central Retinal Vein Occlusion
• Intervention / Treatment: Drug: Tissue Plasminogen Activator

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College/ New York Presbyterian hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: intra-arterial thrombolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of retinal perfusion on the 1-week fluorescein angiogram, with no severe complications.	One week

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with 3 or more lines of visual acuity improvement during follow up.	6 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Y Pierre Gobin, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: macular edema; vision loss; central retinal vein occlusion; relative afferent papillary defect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: CRVO-IAT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No