Download ที่มา : http://clinicaltrial.gov/ct2/show/NCT00813059?term=intravitreal

ที่มา :
http://clinicaltrial.gov/ct2/show/NCT00813059?term=intravitreal+bevacizumab+opti
c+neuropathy&rank=1Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic
Optic Neuropathy
This study is currently recruiting participants.
Verified by Mount Sinai Hospital, Canada, April 2009
First Received: December 19, 2008 Last Updated: April 13, 2009 History of Changes
Sponsor: Mount Sinai Hospital, Canada
Information provided by: 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
Non-Arteritic Anterior Ischemic Optic Drug: Intra-vitreal injection of bevacizumab
Neuropathy
(1.25mg/0.05ml)
Study Type:
Interventional
Study Design:
Allocation: Non-Randomized
Control: Uncontrolled
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Phas
e
Phas
e II
Primary Purpose: Treatment
Official Title:
Intravitreal Bevacizumab for Treatment of the Second Eye With NonArteritic Ischemic Optic Neuropathy
Resource links provided by NLM:
Drug Information available for: Bevacizumab
U.S. FDA Resources
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 => ใช้ แค่ 10 คน แต่ ไม่ ได้ แสดงวิธีการคานวณ sample size
Study Start Date:
February 2009
Estimated Study Completion Date:
January 2011
Estimated Primary Completion Date:
January 2011 (Final data collection date for primary
outcome measure)
Arms
1: Experimental
Intervention: Drug: Intra-vitreal injection of
bevacizumab (1.25mg/0.05ml)
Assigned Interventions
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 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 agerelated 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
Ages Eligible for Study:
Genders Eligible for Study:
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria:

30 Years and older
Both
No
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:
o
uncontrolled glaucoma
o
pregnancy
o
lactation
o
proliferative diabetic retinopathy
o
active clinically significant diabetic macular edema
o
active uveitis
o
prior treatment with intraocular steroids that incited significant
increase in intra-ocular pressure
o
other known causes of decreased visual acuity in the recently
involved eye such as significant dry or wet macular degeneration
o
previous history of other optic neuropathies
o
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813059
Contacts
Contact: Edward Margolin, MD
416-586-4800 ext 5137 [email protected]
Contact: Ligia Borcea, BS
416-586-4800 ext 5137 [email protected]
Locations
Canada, Ontario
Mount Sinai Hospital, University of Toronto
Toronto, Ontario, Canada, M5G 1X5
Contact: Edward Margolin, MD 416-586-4800 ext 5137
Principal Investigator: Edward Margolin, MD, FRSCS
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator:
Recruiting
[email protected]
Edward Margolin Mount Sinai Hospital, University of Toronto
More Information
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):13449. Epub 2006 Jul 19.
Responsible Party:
University of Toronto ( Edward Margolin, MD, FRSCS )
ClinicalTrials.gov Identifier:
NCT00813059
Other Study ID Numbers:
edmargolin
Study First Received:
December 19, 2008
Last Updated:
April 13, 2009
History of Changes
Health Authority:
Canada: Health Canada
Keywords provided by Mount Sinai Hospital, Canada:
NAION
bevacizumab
Additional relevant MeSH terms:
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Eye Diseases
Bevacizumab
Ischemia
Demyelinating Diseases
Polyneuropathies
Neurologic Manifestations
Neurotoxicity Syndromes
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Disorders of Environmental Origin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
ClinicalTrials.gov processed this record on January 06, 2011
Back to top of Main Content
Contact Help Desk
Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicine,
U.S. National Institutes of Health, U.S. Department of Health & Human Services,
USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act