The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- OCULAR IBDDAM INDEX [14 months]
Iranian Behcet's disease Dynamic Activity measurement
- VISUAL ACUITY [14]
Check visual acuity with snellen chart by ophthalmologist
Secondary Outcome Measures
- Inflammation in retin [14]
Check inflammation in retin by ophthalmologist
- Inflammation in posterior chamber [14]
Check inflammation in posterior uvea by ophthalmologist
- inflammation in anterior chamber [14]
check inflammation in anterior chamber by ophthalmologist
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rheumatology Research Center, Tehran University of Medical Science | Tehran | Iran, Islamic Republic of | 1411713135 |
Sponsors and Collaborators
- Tehran University of Medical Sciences
Investigators
- Principal Investigator: Farhad Shahram, Professor, Rheumatology Research Center, Tehran University of Medical Science
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11192