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

Behcet's Disease Clinical Trial

Official title:

The Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01306955
• Other study ID #: 11192
• Status: Recruiting
• Phase: Phase 4
• First received: March 1, 2011
• Last updated: March 1, 2011
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2011
• Source: Tehran University of Medical Sciences
• Contact: Farhad Shahram, Professor
• Phone: 0098-21-8802-6956
• Email: Shahramf[@]tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Disease

Intervention

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

Other:
• dextrose water 5%
intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rheumatology Research Center, Tehran University of Medical Science	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCULAR IBDDAM INDEX	Iranian Behcet's disease Dynamic Activity measurement	14 months	No
Primary	VISUAL ACUITY	Check visual acuity with snellen chart by ophthalmologist	14	No
Secondary	Inflammation in retin	Check inflammation in retin by ophthalmologist	14	No
Secondary	Inflammation in posterior chamber	Check inflammation in posterior uvea by ophthalmologist	14	No
Secondary	inflammation in anterior chamber	check inflammation in anterior chamber by ophthalmologist	14	No