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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