The goal of this study is to examine the efficacy of 1gram/month pulse methylprednisolone 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 ora l prednisolone, 0.5 mg/kg. After that, all the patients were followed up with no other therapeutic intervention. The patients will be visited every 2 months by an ophthalmologist for 6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual acuity, retinal and posterior chamber inflammation index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011235235N1
Registration date:2011-01-28, 1389/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-28, 1389/11/08
Registrant information
Name
Farhad Shahram
Name of organization / entity
Rheumatology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21888330033
Email address
shahramf@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rheumatology Research Center, Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of pulse methylprednisolon in improvement of posterior segment involvement in Behcet's ocular lesions: a double blind pilot study
Public title
The efficacy of puls methylprednisolone in the treatment of patients with ocular involvement in Behcet′s disease
Purpose
Treatment
Inclusion/Exclusion 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, or 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
Age
From 10 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Tehran University of Medical Science and Health Services, Enghelab Ave., Tehran
City
Tehran
Postal code
Approval date
2010-11-09, 1389/08/18
Ethics committee reference number
11192
Health conditions studied
1
Description of health condition studied
ocular involvement in behcet′s disease
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease
Primary outcomes
1
Description
Ocular IBDDAM INDEX
Timepoint
Before and 2 months after treatment
Method of measurement
ophthalmologist record
2
Description
Visual acuity
Timepoint
Before intervention and then every 2 months for 6 months
Method of measurement
ophthalmologist record
Secondary outcomes
1
Description
Inflammation in retina
Timepoint
Before and two months after intervention
Method of measurement
ophthalmologist record
Intervention groups
1
Description
Intervention group: Intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at the beginning of treatment
Category
Treatment - Drugs
2
Description
Control group: 100cc D/w5% on 3 consecutive days at the beginning of treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Behcet′s Clinic, Rheumatology Research Center
Full name of responsible person
Dr. Mastaneh Mohammadi
Street address
Shariati Hospital, Kargar Ave., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rheumatology Research Center
Full name of responsible person
Dr. Farhad Shahram
Street address
Rheumatology Research Center, Shariati Hospital, Karg ar Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rheumatology Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Mastaneh Mohammadi
Position
Fellowship of Rheumatology
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave., Rheumatology Research Center
City
Tehran
Postal code
1411713135
Phone
+98 21 8802 6956
Fax
+98 21888026956
Email
MastanehMohammadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Farhad Shahram
Position
Rheumatologist
Other areas of specialty/work
Street address
Rheumatology Research Center, Shariati Hospital, Kargar Ave., Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8802 6956
Fax
+98 21888026956
Email
shahramf@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Mastaneh Mohammadi
Position
Fellowship Of Rheumatology
Other areas of specialty/work
Street address
Rheumatology Research Center, Shariati Hospital, Kargar Ave., Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8802 6956
Fax
+98 21 8802 6956
Email
MastanehMohammadi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)