Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion

NCT01581411 | Completed Phase 1

• 1 other identifier: CRVO-IAT1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Retinal Vein Occlusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  One week

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

IA t-PA

EXPERIMENTAL

intra-ophthalmic artery injection of tissue plasminogen activator

Drug: Tissue Plasminogen Activator

Interventions

Tissue Plasminogen Activator DRUG

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

Also known as: intra-arterial thrombolysis

IA t-PA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College/ New York Presbyterian hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema; Vision Disorders

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Y Pierre Gobin, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 20, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 6, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)