Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 8/8/2018 |
| Start Date: | January 2012 |
| End Date: | November 2015 |
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.
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.
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.
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.
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.
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Y Pierre Gobin, MD
Phone: 212-746-4998
Click here to add this to my saved trials
