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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone | Active Comparator | patients who received methylprednisolone |
|
| dextrose water 5% | Placebo Comparator | patients who received dextrose water 5% as placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylorednisolone | Drug | intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| OCULAR IBDDAM INDEX | Iranian Behcet's disease Dynamic Activity measurement | 14 months |
| VISUAL ACUITY | Check visual acuity with snellen chart by ophthalmologist | 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation in retin | Check inflammation in retin by ophthalmologist | 14 |
| Inflammation in posterior chamber | Check inflammation in posterior uvea by ophthalmologist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farhad Shahram, Professor | Contact | 0098-21-8802-6956 | Shahramf@tums.ac.ir | |
| Mohammadi mastaneh, MD | Contact | 0098-21-8802-6956 | Mastanehmohammadi88@gmale.com |
| Name | Affiliation | Role |
|---|---|---|
| Farhad Shahram, Professor | Rheumatology Research Center, Tehran University of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Research Center, Tehran University of Medical Science | Recruiting | Tehran | 1411713135 | Iran |
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| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| D031300 | Retinal Vasculitis |
| D015866 | Uveitis, Posterior |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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| dextrose water 5% | Other | intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment |
|
| 14 |
| inflammation in anterior chamber | check inflammation in anterior chamber by ophthalmologist | 14 |
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D012164 | Retinal Diseases |