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Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

Primary Purpose

Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Avastin and Triamcinolone
placebo
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Labbafinejad medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Avastin and Triamcinolone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes of Best corrected visual acuity(BCVA)
outcome method of measurement: Snellen chart

Secondary Outcome Measures

Changes of Visual Field
Automated perimeter

Full Information

First Posted
March 8, 2011
Last Updated
April 5, 2011
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01330524
Brief Title
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo
Official Title
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Nonarteritic Anterior Ischemic Optic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avastin and Triamcinolone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Avastin and Triamcinolone
Intervention Description
1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
2mg placebo
Primary Outcome Measure Information:
Title
Changes of Best corrected visual acuity(BCVA)
Description
outcome method of measurement: Snellen chart
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Changes of Visual Field
Description
Automated perimeter
Time Frame
6 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Labbafinejad medical center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
morteza entezari, Associate Professor
Phone
00982122585952
Email
entmort@hotmail.com
First Name & Middle Initial & Last Name & Degree
morteza entezari, associat of profesor

12. IPD Sharing Statement

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Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

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