Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

NCT ID: NCT01330524

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Avastin and Triamcinolone

Group Type ACTIVE_COMPARATOR

Avastin and Triamcinolone

Intervention Type DRUG

1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

2mg placebo

Interventions

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Avastin and Triamcinolone

1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal

Intervention Type DRUG

placebo

2mg placebo

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ophthalmic Research center

Locations

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Labbafinejad medical center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Facility Contacts

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morteza entezari, Associate Professor

Role: primary

00982122585952

Other Identifiers

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8749

Identifier Type: -

Identifier Source: org_study_id

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