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

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

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.

Study Overview

• Status: Unknown
• Conditions: Behcet's Disease
• Intervention / Treatment: Drug: methylorednisolone; Other: dextrose water 5%

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Farhad Shahram, Professor; Phone Number: 0098-21-8802-6956; Email: Shahramf@tums.ac.ir
• Study Contact Backup: Name: Mohammadi mastaneh, MD; Phone Number: 0098-21-8802-6956; Email: Mastanehmohammadi88@gmale.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1411713135
    • Recruiting
    • Rheumatology Research Center, Tehran University of Medical Science
    • Contact: Shahram Farhad, Professor; Phone Number: 0098-21-8802-6956; Email: Shahramf@tums.ac.ir
    • Contact: Mastaneh Mohammadi, MD; Phone Number: 0098-21-8802-6956; Email: Mastanehmohammadi88@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: methylprednisolone; patients who received methylprednisolone	Drug: methylorednisolone; intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment
Placebo Comparator: dextrose water 5%; patients who received dextrose water 5% as placebo	Other: dextrose water 5%; intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation in retin	Check inflammation in retin by ophthalmologist	14
Inflammation in posterior chamber	Check inflammation in posterior uvea by ophthalmologist	14
inflammation in anterior chamber	check inflammation in anterior chamber by ophthalmologist	14

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Farhad Shahram, Professor, Rheumatology Research Center, Tehran University of Medical Science

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Estimate): March 2, 2011
• Last Update Submitted That Met QC Criteria: March 1, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: methylprednisolone; posterior uveitis; retinal vasculitis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome
• Other Study ID Numbers: 11192 (DAIDS ES Registry Number)