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NCT01330524 Clinical Trial

Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

Acute Nonarteritic Anterior Ischemic Optic Neuropathy Clinical Trial

Official title:
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01330524
Other study ID # 8749
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received March 8, 2011
Last updated April 5, 2011
Start date January 2010
Est. completion date November 2011

Study information
Verified date November 2009
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 16
Est. completion date November 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Avastin and Triamcinolone
1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal
Other:
• placebo
2mg placebo

Locations
Country Name City State
Iran, Islamic Republic of Labbafinejad medical center Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of Best corrected visual acuity(BCVA) outcome method of measurement: Snellen chart 6 month Yes
Secondary Changes of Visual Field Automated perimeter 6 month Yes