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

NCT01306955 | Unknown Phase 4 DMC

• 1 other identifier: 11192
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet's Disease

Keywords

retinal vasculitis; posterior uveitis; methylprednisolone

Outcome Measures

Primary Outcomes (2)

• OCULAR IBDDAM INDEX

  Iranian Behcet's disease Dynamic Activity measurement

  14 months

• VISUAL ACUITY

  Check visual acuity with snellen chart by ophthalmologist

  14

Secondary Outcomes (3)

• Inflammation in retin

  14

• Inflammation in posterior chamber

  14

• inflammation in anterior chamber

  14

Study Arms (2)

methylprednisolone

ACTIVE COMPARATOR

patients who received methylprednisolone

Drug: methylorednisolone

dextrose water 5%

PLACEBO COMPARATOR

patients who received dextrose water 5% as placebo

Other: dextrose water 5%

Interventions

methylorednisolone DRUG

intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment

methylprednisolone

dextrose water 5% OTHER

intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment

dextrose water 5%

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Rheumatology Research Center, Tehran University of Medical Science

Tehran, 1411713135, Iran

RECRUITING

MeSH Terms

Conditions

Behcet Syndrome; Retinal Vasculitis; Uveitis, Posterior

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Retinal Diseases

Study Officials

• Farhad Shahram, Professor

  Rheumatology Research Center, Tehran University of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farhad Shahram, Professor

CONTACT

0098-21-8802-6956; Shahramf@tums.ac.ir

Mohammadi mastaneh, MD

CONTACT

0098-21-8802-6956; Mastanehmohammadi88@gmale.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 2, 2011

Record last verified: 2011-03

Locations

IR (1)