Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01330524
First received: March 8, 2011
Last updated: April 5, 2011
Last verified: November 2009

March 8, 2011
April 5, 2011
January 2010
November 2010   (final data collection date for primary outcome measure)
Changes of Best corrected visual acuity(BCVA) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
outcome method of measurement: Snellen chart
Same as current
Complete list of historical versions of study NCT01330524 on ClinicalTrials.gov Archive Site
Changes of Visual Field [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Automated perimeter
Same as current
Not Provided
Not Provided
 
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Nonarteritic Anterior Ischemic Optic Neuropathy
  • Drug: Avastin and Triamcinolone
    1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal
  • Other: placebo
    2mg placebo
  • Active Comparator: Avastin and Triamcinolone
    Intervention: Drug: Avastin and Triamcinolone
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
November 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Not Provided
Iran, Islamic Republic of
 
NCT01330524
8749
Not Provided
morteza entezari, Ophthalmic Research center
Shahid Beheshti Medical University
Not Provided
Not Provided
Shahid Beheshti Medical University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP