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

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ClinicalTrials.gov Identifier: NCT01306955
Recruitment Status : Unknown
Verified March 2011 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Information provided by:
Tehran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Behcet's Disease Drug: methylorednisolone Other: dextrose water 5% Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : August 2011

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

Primary Outcome Measures :
  1. OCULAR IBDDAM INDEX [ Time Frame: 14 months ]
    Iranian Behcet's disease Dynamic Activity measurement

  2. VISUAL ACUITY [ Time Frame: 14 ]
    Check visual acuity with snellen chart by ophthalmologist

Secondary Outcome Measures :
  1. Inflammation in retin [ Time Frame: 14 ]
    Check inflammation in retin by ophthalmologist

  2. Inflammation in posterior chamber [ Time Frame: 14 ]
    Check inflammation in posterior uvea by ophthalmologist

  3. inflammation in anterior chamber [ Time Frame: 14 ]
    check inflammation in anterior chamber by ophthalmologist

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306955

Contact: Farhad Shahram, Professor 0098-21-8802-6956 Shahramf@tums.ac.ir
Contact: Mohammadi mastaneh, MD 0098-21-8802-6956 Mastanehmohammadi88@gmale.com

Iran, Islamic Republic of
Rheumatology Research Center, Tehran University of Medical Science Recruiting
Tehran, Iran, Islamic Republic of, 1411713135
Contact: Shahram Farhad, Professor    0098-21-8802-6956    Shahramf@tums.ac.ir   
Contact: Mastaneh Mohammadi, MD    0098-21-8802-6956    Mastanehmohammadi88@gmail.com   
Sponsors and Collaborators
Tehran University of Medical Sciences
Principal Investigator: Farhad Shahram, Professor Rheumatology Research Center, Tehran University of Medical Science

Responsible Party: Farhad Shahram, MD, Professor, Rheumatology Research Center
ClinicalTrials.gov Identifier: NCT01306955     History of Changes
Other Study ID Numbers: 11192
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: March 2011

Keywords provided by Tehran University of Medical Sciences:
retinal vasculitis
posterior uveitis

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents