Clinical trial NCT01306955: The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Behcet's Disease
Keywords: retinal vasculitis
posterior uveitis
methylprednisolone
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: OCULAR IBDDAM INDEX
timeFrame: 14 months
measure: VISUAL ACUITY
timeFrame: 14
Secondary outcomes:
measure: Inflammation in retin
timeFrame: 14
measure: Inflammation in posterior chamber
timeFrame: 14
measure: inflammation in anterior chamber
timeFrame: 14
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center, Tehran University of Medical Science
Study officials:
affiliation: Rheumatology Research Center, Tehran University of Medical Science
name: Farhad Shahram, Professor
role: PRINCIPAL_INVESTIGATOR
References: