- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813059
Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic Optic Neuropathy
Intravitreal Bevacizumab for Treatment of the Second Eye With Non-Arteritic Ischemic Optic Neuropathy
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Edward Margolin, MD
- Phone Number: 5137 416-586-4800
- Email: mjiharev@mtsinai.on.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Recruiting
- Mount Sinai Hospital, University of Toronto
-
Contact:
- Edward Margolin, MD
- Phone Number: 5137 416-586-4800
- Email: mjiharev@mtsinai.on.ca
-
Principal Investigator:
- Edward Margolin, MD, FRSCS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Pars plana intra-vitreal injection of bevacizumab (1.25 mg/0.05
ml)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients who gained three or more lines of vision at six months
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edward Margolin, Mount Sinai Hospital, University of Toronto
Publications and helpful links
General 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. doi: 10.1097/WNO.0b013e31814b273d. 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. doi: 10.1097/WNO.0b013e31814a61ae. 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. doi: 10.1136/bjo.2006.099598. Epub 2006 Jul 19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Eye Diseases
- Cranial Nerve Diseases
- Ischemia
- Optic Nerve Diseases
- Optic Neuropathy, Ischemic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- edmargolin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-arteritic Anterior Ischemic Optic Neuropathy
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Shahid Beheshti University of Medical SciencesUnknownNon-Arteritic Anterior Ischemic Optic Neuropathy (NAION)Iran, Islamic Republic of
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Shahid Beheshti University of Medical SciencesUnknownNAION( Non-arteritic Anterior Ischemic Optic Neuropathy)Iran, Islamic Republic of
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Emory UniversityCompletedNon-Arteritic Anterior Ischemic Optic NeuropathyUnited States
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Quark PharmaceuticalsTerminatedNon Arteritic Anterior Ischemic Optic NeuropathyUnited States, Australia, Germany, China, India, Italy, Singapore, Israel
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Wills EyeUnited States Department of DefenseCompletedTrauma | Multiple Sclerosis (MS) | Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)United States
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Quark PharmaceuticalsCompletedOptic Atrophy | Non-arteritic Anterior Ischemic Optic NeuropathyUnited States, Israel
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Rigshospitalet, DenmarkUniversity of Colorado, Denver; King's College Hospital NHS Trust; Odense University... and other collaboratorsRecruitingNon-arteritic Ischemic Optic Neuropathy | Optic Disk DrusenDenmark, United Kingdom, United States, Australia, Canada, France, Iran, Islamic Republic of, Israel, New Zealand
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Omar SaidCompletedNon-arteritic Ischemic Optic NeuropathyEgypt
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University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Completed
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