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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Tehran University of Medical Sciences

Current Primary Outcome:

  • OCULAR IBDDAM INDEX [ Time Frame: 14 months ]
    Iranian Behcet's disease Dynamic Activity measurement
  • VISUAL ACUITY [ Time Frame: 14 ]
    Check visual acuity with snellen chart by ophthalmologist


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Inflammation in retin [ Time Frame: 14 ]
    Check inflammation in retin by ophthalmologist
  • Inflammation in posterior chamber [ Time Frame: 14 ]
    Check inflammation in posterior uvea by ophthalmologist
  • inflammation in anterior chamber [ Time Frame: 14 ]
    check inflammation in anterior chamber by ophthalmologist


Original Secondary Outcome: Same as current

Information By: Tehran University of Medical Sciences

Dates:
Date Received: March 1, 2011
Date Started: February 2010
Date Completion: August 2011
Last Updated: March 1, 2011
Last Verified: March 2011