跳至主要内容
临床试验/NCT01306955
NCT01306955Unknown4 期

The Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot Study

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

patients who received methylprednisolone

干预措施: methylorednisolone (Drug)

dextrose water 5%

Placebo Comparator

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)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验