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Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

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ClinicalTrials.gov Identifier: NCT01330524
Recruitment Status : Unknown
Verified November 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 7, 2011
Last Update Posted : April 7, 2011
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected trough vitreal and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.

Condition or disease Intervention/treatment Phase
Acute Nonarteritic Anterior Ischemic Optic Neuropathy Drug: Avastin and Triamcinolone Other: placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Study Start Date : January 2010
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2011


Arm Intervention/treatment
Active Comparator: Avastin and Triamcinolone Drug: Avastin and Triamcinolone
1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal

Placebo Comparator: Placebo Other: placebo
2mg placebo




Primary Outcome Measures :
  1. Changes of Best corrected visual acuity(BCVA) [ Time Frame: 6 month ]
    outcome method of measurement: Snellen chart


Secondary Outcome Measures :
  1. Changes of Visual Field [ Time Frame: 6 month ]
    Automated perimeter



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days)

Exclusion criteria:

  • Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy)
  • Neurologic defect
  • Abnormal ESR, CRP, any history of retina or vitreal surgery
  • Severe corneal opacity which makes retina examination impossible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330524


Locations
Iran, Islamic Republic of
Labbafinejad medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: morteza entezari, Associate Professor    00982122585952    entmort@hotmail.com   
Principal Investigator: morteza entezari, associat of profesor         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

Responsible Party: morteza entezari, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01330524     History of Changes
Other Study ID Numbers: 8749
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: November 2009

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action