Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

Completed · Phase 1

Conditions studied: Central Retinal Vein Occlusion

In brief

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.

Key facts

Study ID

NCT01581411

Run by

Weill Medical College of Cornell University

People needed

1

Starts

2012-01-01

Expected to finish

2015-11-01

Last updated by the study team

2018-08-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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