Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic Optic Neuropathy
Information source: Mount Sinai Hospital, Canada
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Arteritic Anterior Ischemic Optic Neuropathy
Intervention: Intra-vitreal injection of bevacizumab (1.25mg/0.05ml) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Mount Sinai Hospital, Canada Official(s) and/or principal investigator(s):
Edward Margolin, Principal Investigator, Affiliation: Mount Sinai Hospital, University of Toronto
Overall contact:
Edward Margolin, MD, Phone: 416-586-4800, Ext: 5137, Email: lborcea@mtsinai.on.ca
Summary
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.
Clinical Details
Official title: Intravitreal Bevacizumab for Treatment of the Second Eye With Non-Arteritic Ischemic Optic Neuropathy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients who gained three or more lines of vision at six months
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 our
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 we 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, we 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
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Edward Margolin, MD, Phone: 416-586-4800, Ext: 5137, Email: lborcea@mtsinai.on.ca
Mount Sinai Hospital, University of Toronto, Toronto, Ontario M5G 1X5, Canada; Recruiting
Edward Margolin, MD, Phone: 416-586-4800, Ext: 5137, Email: lborcea@mtsinai.on.ca
Edward Margolin, MD, FRSCS, Principal Investigator
Additional Information
Related publications: Bennett JL, Thomas S, Olson JL, Mandava N. Treatment of nonarteritic anterior ischemic optic neuropathy with intravitreal bevacizumab. J Neuroophthalmol. 2007 Sep;27(3):238-40. No abstract available. Kelman SE. Intravitreal triamcinolone or bevacizumab for nonarteritic anterior ischemic optic neuropathy: do they merit further study? J Neuroophthalmol. 2007 Sep;27(3):161-3. No abstract available. Fung AE, Rosenfeld PJ, Reichel E. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br J Ophthalmol. 2006 Nov;90(11):1344-9. Epub 2006 Jul 19.
Starting date: February 2009
Ending date: January 2011
Last updated: April 13, 2009
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