The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease

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

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-08-31

Brief Summary

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The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem was confirmed with new international criteria of Behcet's disease (ICBD) will be randomly assigned into one of the two equal groups of intervention or control. Behcet's patients are those with ocular involvement who were under the same cytotoxic treatment with cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5 mg/kg. After that, all the patients were followed up with no other therapeutic intervention by study group. The patients will be visited every 2 months by an ophthalmologist and study group for 6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual acuity, retinal and ocular posterior chamber inflammation index.

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Detailed Description

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Conditions

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Behcet's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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methylprednisolone

patients who received methylprednisolone

Group Type ACTIVE_COMPARATOR

methylorednisolone

Intervention Type DRUG

intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment

dextrose water 5%

patients who received dextrose water 5% as placebo

Group Type PLACEBO_COMPARATOR

dextrose water 5%

Intervention Type OTHER

intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment

Interventions

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methylorednisolone

intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment

Intervention Type DRUG

dextrose water 5%

intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed Behcet's disease according to international criteria
* New or relapse of retinal vasculitis who received any cytotoxic or glucocorticoid since 2 months ago
* New or relapse of severe posterior uveitis who are candidate for cyclophosphamide and azathioprine according to their physician

Exclusion Criteria

* Not Signing the informed consent
* Visual acuity lower than 1/10 by Snellen chart
* Presence of infectious diseases such as TB
* Presence of diabetes mellitus, hypertension, heart disease, liver disease, renal disease, or edema
* Presence of other glucocorticoid consumption contraindications

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No