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Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Shahid Beheshti University of Medical Sciences
Information provided by:
Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01330524
First received: March 8, 2011
Last updated: April 5, 2011
Last verified: November 2009
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | March 8, 2011 | ||
| Last Updated Date | April 5, 2011 | ||
| Start Date ICMJE | January 2010 | ||
| Estimated Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Changes of Best corrected visual acuity(BCVA) [ Time Frame: 6 month ] outcome method of measurement: Snellen chart |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE |
Changes of Visual Field [ Time Frame: 6 month ] Automated perimeter |
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| 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 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Acute Nonarteritic Anterior Ischemic Optic Neuropathy | ||
| Intervention ICMJE |
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| Study Arms |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Unknown status | ||
| Estimated Enrollment ICMJE | 16 | ||
| Estimated Completion Date | November 2011 | ||
| Estimated Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Sex/Gender |
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| 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 | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | 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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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