Clinical trial NCT01581411: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Retinal Vein Occlusion
Keywords: central retinal vein occlusion
macular edema
vision loss
relative afferent papillary defect
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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.

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.

Primary outcomes:
measure: Improvement of retinal perfusion on the 1-week fluorescein angiogram, with no severe complications.
timeFrame: One week
Secondary outcomes:
measure: Number of patients with 3 or more lines of visual acuity improvement during follow up.
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College/ New York Presbyterian hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Y Pierre Gobin, MD
role: PRINCIPAL_INVESTIGATOR
References: