Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic Optic Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Mount Sinai Hospital, Canada.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Edward Margolin, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00813059
First received: December 19, 2008
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

Non-Arteritic Ischemic Optic Neuropathy (NAION) is a disease producing swelling of the optic nerve (the "cable" going from the eye to the brain) resulting in decreased vision. About 15% of patients will experience NAION in the second eye; many of these patients will be left legally blind.

Currently, there is no treatment for NAION and for patients in whom the second eye becomes involved by the disease the outcome can be devastating.

The investigators are conducting a study where the investigators will inject a medication into the involved eye of patients with NAION. This medication might decrease the swelling of the optic nerve and improve their vision in that eye.


Condition Intervention Phase
Non-arteritic Anterior Ischemic Optic Neuropathy
Drug: Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Treatment of the Second Eye With Non-Arteritic Ischemic Optic Neuropathy

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Percentage of patients who gained three or more lines of vision at six months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)
Pars plana intra-vitreal injection of bevacizumab (1.25 mg/0.05 ml)

Detailed Description:

NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it. This leads to the release of vascular endothelial growth factor (VEGF) and swelling of the affected area of the nerve. Vascular endothelial growth factor (VEGF) causes a rapid and reversible increase in vascular permeability and thus vasogenic edema of the affected area of the optic nerve head. Subsequently, increased pressure from the swelling of the affected segment causes compression and infarction of the previously not affected parts of the optic nerve by creating a sort-of "compartment syndrome".

Bevacizumab is a known anti-Vascular Endothelial Growth Factor (VEGF) agent. It is the investigators hypothesis that by injecting bevacizumab intra-vitreally the vasogenic edema will be reduced, preserving viable but threatened optic nerve tissue. One recent case report described a patient with sequential NAION treated with intra-vitreal bevacizumab who demonstrated significant improvement in visual acuity and on visual field testing (1). An editorial in the same issue of the Journal of Neuro-Ophthalmology in which this article appeared suggested that if the small studies evaluating intra-vitreal injections of bevacizumab in NAION would support its use in this disease, a large multi-center trial could be planned (2).

Intra-vitreal injections of bevacizumab have proven to be very safe in treatment of age-related macular degeneration (3). Because the patients that the investigators are planning to enroll in this study are faced with the real possibility of blindness with no therapeutic modality currently available to improve their visual outcome, the investigators believe that offering them intra-vitreal bevacizumab injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed NAION (within the past 30 days but preferably within the first 14).

Exclusion Criteria:

  • Patients who are unable to give informed consent
  • Patient with:

    • uncontrolled glaucoma
    • pregnancy
    • lactation
    • proliferative diabetic retinopathy
    • active clinically significant diabetic macular edema
    • active uveitis
    • prior treatment with intraocular steroids that incited significant increase in intra-ocular pressure
    • other known causes of decreased visual acuity in the recently involved eye such as significant dry or wet macular degeneration
    • previous history of other optic neuropathies
    • previous history of ocular trauma that resulted in decreased visual acuity
  • Patients with baseline amblyopia in the newly involved eye and visual acuity worse than 20/50 prior to the onset of NAION
  • Previous treatment for any ocular condition with any investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813059

Contacts
Contact: Edward Margolin, MD 416-586-4800 ext 5137 mjiharev@mtsinai.on.ca

Locations
Canada, Ontario
Mount Sinai Hospital, University of Toronto Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Edward Margolin, MD    416-586-4800 ext 5137    mjiharev@mtsinai.on.ca   
Principal Investigator: Edward Margolin, MD, FRSCS         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Edward Margolin Mount Sinai Hospital, University of Toronto
  More Information

Publications:
Responsible Party: Edward Margolin, MD, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT00813059     History of Changes
Other Study ID Numbers: edmargolin
Study First Received: December 19, 2008
Last Updated: February 6, 2012
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
NAION
bevacizumab

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Cardiovascular Diseases
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014