The Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- OCULAR IBDDAM INDEX
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 70 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
methylprednisolone
patients who received methylprednisolone
干预措施: methylorednisolone (Drug)
dextrose water 5%
patients who received dextrose water 5% as placebo
干预措施: dextrose water 5% (Other)
结局指标
主要结局
OCULAR IBDDAM INDEX
时间窗: 14 months
Iranian Behcet's disease Dynamic Activity measurement
VISUAL ACUITY
时间窗: 14
Check visual acuity with snellen chart by ophthalmologist
次要结局
- Inflammation in retin(14)
- Inflammation in posterior chamber(14)
- inflammation in anterior chamber(14)
