search
Back to results

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

Primary Purpose

Behcet's Disease

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
methylorednisolone
dextrose water 5%
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet's Disease focused on measuring retinal vasculitis, posterior uveitis, methylprednisolone

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumatology Research Center, Tehran University of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

methylprednisolone

dextrose water 5%

Arm Description

patients who received methylprednisolone

patients who received dextrose water 5% as placebo

Outcomes

Primary Outcome Measures

OCULAR IBDDAM INDEX
Iranian Behcet's disease Dynamic Activity measurement
VISUAL ACUITY
Check visual acuity with snellen chart by ophthalmologist

Secondary Outcome Measures

Inflammation in retin
Check inflammation in retin by ophthalmologist
Inflammation in posterior chamber
Check inflammation in posterior uvea by ophthalmologist
inflammation in anterior chamber
check inflammation in anterior chamber by ophthalmologist

Full Information

First Posted
March 1, 2011
Last Updated
March 1, 2011
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01306955
Brief Title
The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet's Disease
Keywords
retinal vasculitis, posterior uveitis, methylprednisolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
methylprednisolone
Arm Type
Active Comparator
Arm Description
patients who received methylprednisolone
Arm Title
dextrose water 5%
Arm Type
Placebo Comparator
Arm Description
patients who received dextrose water 5% as placebo
Intervention Type
Drug
Intervention Name(s)
methylorednisolone
Intervention Description
intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment
Intervention Type
Other
Intervention Name(s)
dextrose water 5%
Intervention Description
intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment
Primary Outcome Measure Information:
Title
OCULAR IBDDAM INDEX
Description
Iranian Behcet's disease Dynamic Activity measurement
Time Frame
14 months
Title
VISUAL ACUITY
Description
Check visual acuity with snellen chart by ophthalmologist
Time Frame
14
Secondary Outcome Measure Information:
Title
Inflammation in retin
Description
Check inflammation in retin by ophthalmologist
Time Frame
14
Title
Inflammation in posterior chamber
Description
Check inflammation in posterior uvea by ophthalmologist
Time Frame
14
Title
inflammation in anterior chamber
Description
check inflammation in anterior chamber by ophthalmologist
Time Frame
14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farhad Shahram, Professor
Phone
0098-21-8802-6956
Email
Shahramf@tums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammadi mastaneh, MD
Phone
0098-21-8802-6956
Email
Mastanehmohammadi88@gmale.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhad Shahram, Professor
Organizational Affiliation
Rheumatology Research Center, Tehran University of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Research Center, Tehran University of Medical Science
City
Tehran
ZIP/Postal Code
1411713135
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahram Farhad, Professor
Phone
0098-21-8802-6956
Email
Shahramf@tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Mastaneh Mohammadi, MD
Phone
0098-21-8802-6956
Email
Mastanehmohammadi88@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs