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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01306955
First received: March 1, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention Phase
Behcet's Disease
Drug: methylorednisolone
Other: dextrose water 5%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • OCULAR IBDDAM INDEX [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Iranian Behcet's disease Dynamic Activity measurement

  • VISUAL ACUITY [ Time Frame: 14 ] [ Designated as safety issue: No ]
    Check visual acuity with snellen chart by ophthalmologist


Secondary Outcome Measures:
  • Inflammation in retin [ Time Frame: 14 ] [ Designated as safety issue: No ]
    Check inflammation in retin by ophthalmologist

  • Inflammation in posterior chamber [ Time Frame: 14 ] [ Designated as safety issue: No ]
    Check inflammation in posterior uvea by ophthalmologist

  • inflammation in anterior chamber [ Time Frame: 14 ] [ Designated as safety issue: No ]
    check inflammation in anterior chamber by ophthalmologist


Estimated Enrollment: 34
Study Start Date: February 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306955

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

Locations
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
Investigators
Principal Investigator: Farhad Shahram, Professor Rheumatology Research Center, Tehran University of Medical Science
  More Information

No publications provided

Responsible Party: Farhad Shahram, MD, Professor, Rheumatology Research Center
ClinicalTrials.gov Identifier: NCT01306955     History of Changes
Other Study ID Numbers: 11192
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Behcet Syndrome
Cardiovascular Diseases
Eye Diseases
Mouth Diseases
Panuveitis
Skin Diseases
Skin Diseases, Vascular
Stomatognathic Diseases
Uveal Diseases
Uveitis
Uveitis, Anterior
Vascular Diseases
Vasculitis
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 21, 2014