Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

Tracking Information
First Submitted Date ICMJE	March 8, 2011
First Posted Date ICMJE	April 7, 2011
Last Update Posted Date	April 7, 2011
Study Start Date ICMJE	January 2010
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 5, 2011)	Changes of Best corrected visual acuity(BCVA) [ Time Frame: 6 month ]; outcome method of measurement: Snellen chart
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: April 5, 2011)	Changes of Visual Field [ Time Frame: 6 month ]; Automated perimeter
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo
Official Title ICMJE	Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Intervention ICMJE	Drug: Avastin and Triamcinolone 1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal; Other: placebo 2mg placebo
Study Arms	Active Comparator: Avastin and Triamcinolone Intervention: Drug: Avastin and Triamcinolone; Placebo Comparator: Placebo Intervention: Other: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: April 5, 2011)	16
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	November 2011
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Iran, Islamic Republic of
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01330524
Other Study ID Numbers ICMJE	8749
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	morteza entezari, Ophthalmic Research center
Study Sponsor ICMJE	Shahid Beheshti University of Medical Sciences
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Shahid Beheshti University of Medical Sciences
Verification Date	November 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP