Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

Central Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581411
• Other study ID #: CRVO-IAT1
• Status: Completed
• Phase: Phase 1
• Start date: January 2012
• Est. completion date: November 2015

Study information

• Verified date: August 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medical College/ New York Presbyterian hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of retinal perfusion on the 1-week fluorescein angiogram, with no severe complications.		One week
Secondary	Number of patients with 3 or more lines of visual acuity improvement during follow up.		6 months