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| Sponsor: | Mount Sinai Hospital, Canada |
|---|---|
| Information provided by (Responsible Party): | Edward Margolin, Mount Sinai Hospital, Canada |
| ClinicalTrials.gov Identifier: | NCT00813059 |
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 |
| 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)
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Patient with:
Contacts and Locations| Contact: Edward Margolin, MD | 416-586-4800 ext 5137 | mjiharev@mtsinai.on.ca |
| 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 | |
| Principal Investigator: | Edward Margolin | Mount Sinai Hospital, University of Toronto |
More Information
| 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 |
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NAION bevacizumab |
|
Ischemia Optic Nerve Diseases Optic Neuropathy, Ischemic Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Pathologic Processes Cranial Nerve Diseases Nervous System Diseases Eye Diseases Vascular Diseases Cardiovascular Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Poisoning Substance-Related Disorders Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
