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

Phase 4

• Conditions: Behcet's Disease
• Interventions: Drug: methylorednisolone; Other: dextrose water 5%

• Registration Number: NCT01306955
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Status Verified: 2011-03
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Study First Posted: 2011-03-02
• Last Update Posted: 2011-03-02
• Primary Completion: 2011-07
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone	methylorednisolone	patients who received methylprednisolone
dextrose water 5%	dextrose water 5%	patients who received dextrose water 5% as placebo

Primary Outcome Measures

Name	Time	Method
OCULAR IBDDAM INDEX	14 months	Iranian Behcet's disease Dynamic Activity measurement
VISUAL ACUITY	14	Check visual acuity with snellen chart by ophthalmologist

Secondary Outcome Measures

Name	Time	Method
Inflammation in retin	14	Check inflammation in retin by ophthalmologist
Inflammation in posterior chamber	14	Check inflammation in posterior uvea by ophthalmologist
inflammation in anterior chamber	14	check inflammation in anterior chamber by ophthalmologist

Trial Locations

Locations (1)

Rheumatology Research Center, Tehran University of Medical Science; 🇮🇷 Tehran, Iran, Islamic Republic of