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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Behcet's Disease

Treatments: Drug: methylorednisolone; Other: dextrose water 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT01306955

11192 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

methylprednisolone

Active Comparator group

Description:

patients who received methylprednisolone

Treatment:

Drug: methylorednisolone

dextrose water 5%

Placebo Comparator group

Description:

patients who received dextrose water 5% as placebo

Treatment:

Other: dextrose water 5%