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Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

Primary Purpose

Central Retinal Vein Occlusion

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tissue Plasminogen Activator

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring central retinal vein occlusion, macular edema, vision loss, relative afferent papillary defect

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Weill Cornell Medical College/ New York Presbyterian hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IA t-PA

Arm Description

intra-ophthalmic artery injection of tissue plasminogen activator

Outcomes

Primary Outcome Measures

Improvement of retinal perfusion on the 1-week fluorescein angiogram, with no severe complications.

Secondary Outcome Measures

Number of patients with 3 or more lines of visual acuity improvement during follow up.

Full Information

NCT ID

NCT01581411

First Posted

April 12, 2012

Last Updated

August 2, 2018

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT01581411

Brief Title

Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

5. Study Description

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

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Retinal Vein Occlusion

Keywords

central retinal vein occlusion, macular edema, vision loss, relative afferent papillary defect

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IA t-PA

Arm Type

Experimental

Arm Description

intra-ophthalmic artery injection of tissue plasminogen activator

Intervention Type

Drug

Intervention Name(s)

Tissue Plasminogen Activator

Other Intervention Name(s)

intra-arterial thrombolysis

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement of retinal perfusion on the 1-week fluorescein angiogram, with no severe complications.

Time Frame

One week

Secondary Outcome Measure Information:

Title

Number of patients with 3 or more lines of visual acuity improvement during follow up.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Y Pierre Gobin, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College/ New York Presbyterian hospital

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

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