Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic Optic Neuropathy
Primary Purpose
Non-arteritic Anterior Ischemic Optic Neuropathy
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)
Sponsored by
About this trial
This is an interventional treatment trial for Non-arteritic Anterior Ischemic Optic Neuropathy focused on measuring NAION, bevacizumab
Eligibility 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
Sites / Locations
- Mount Sinai Hospital, University of TorontoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients who gained three or more lines of vision at six months
Secondary Outcome Measures
Full Information
NCT ID
NCT00813059
First Posted
December 19, 2008
Last Updated
February 6, 2012
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00813059
Brief Title
Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic Optic Neuropathy
Official Title
Intravitreal Bevacizumab for Treatment of the Second Eye With Non-Arteritic Ischemic Optic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-arteritic Anterior Ischemic Optic Neuropathy
Keywords
NAION, bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)
Intervention Description
Pars plana intra-vitreal injection of bevacizumab (1.25 mg/0.05 ml)
Primary Outcome Measure Information:
Title
Percentage of patients who gained three or more lines of vision at six months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Margolin, MD
Phone
416-586-4800
Ext
5137
Email
mjiharev@mtsinai.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Margolin
Organizational Affiliation
Mount Sinai Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Margolin, MD
Phone
416-586-4800
Ext
5137
Email
mjiharev@mtsinai.on.ca
First Name & Middle Initial & Last Name & Degree
Edward Margolin, MD, FRSCS
12. IPD Sharing Statement
Citations:
PubMed Identifier
17895825
Citation
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.
Results Reference
background
PubMed Identifier
17895813
Citation
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.
Results Reference
background
PubMed Identifier
16854824
Citation
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.
Results Reference
background
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Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic Optic Neuropathy
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