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

NCT01306955 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-03-02

No results posted yet for this study

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

Interventions

DRUG

methylorednisolone

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

OTHER

dextrose water 5%

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

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Farhad Shahram, Professor · Rheumatology Research Center, Tehran University of Medical Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01306955 on ClinicalTrials.gov