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

Condition(s) targeted: Behcet's Disease

Intervention: methylorednisolone (Drug); dextrose water 5% (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Farhad Shahram, Professor, Principal Investigator, Affiliation: Rheumatology Research Center, Tehran University of Medical Science

Overall contact:
Farhad Shahram, Professor, Phone: 0098-21-8802-6956, Email: Shahramf@tums.ac.ir

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.

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

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

Primary outcome:

OCULAR IBDDAM INDEX

VISUAL ACUITY

Secondary outcome:

Inflammation in retin

Inflammation in posterior chamber

inflammation in anterior chamber

Minimum age: 10 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Farhad Shahram, Professor, Phone: 0098-21-8802-6956, Email: Shahramf@tums.ac.ir

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

Starting date: February 2010
Last updated: March 1, 2011