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临床试验/EUCTR2004-004403-37-DE
EUCTR2004-004403-37-DE进行中(未招募)1 期

Eine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur StandardtherapieA monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-Studie

niversitätsklinikum Heidelberg0 个研究点目标入组 34 人开始时间: 2005年10月28日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
34

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - male and female patients who are at least 18 years old
  • - active, one or two-sided non-infectious uveitis intermedia for at least one year
  • - visual acuity ranging from at least 0,1 up to 0,6 on the worse eye, due to a macula edema (height of fovea > 180 micrometers)
  • - multiple sclerosis (if there is no primary uveitis intermedia)
  • - previous therapy with corticosteroids for a minimum of 4 weeks with at least 0,5 mg/kg body weight which has not been successful
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - a sole uveitis anterior
  • - no macula-edema
  • - an atrophy of the optic nerve after retro-bulbar-neuritis
  • - a peri- or intraocular injection of corticosteroids in the last 3 months
  • - a prior, unsuccesful, systemic treatment with prednisone
  • - a prior, unsuccesful, systemic treatment with acetacolamid (in order to treat macula edema)
  • - a known allergy against human or recombinant Interferon
  • - a psychiatric diagnosed endogenous depression
  • - diseases of the liver for which hepatotoxic pharmaceuticals cannot be tolerated
  • - infectious kinds of uveitis
  • - all systemic diseases except for MS
  • - pregnancy, lactation
  • - no contraception
  • - additional metabolic or psychiatric diseases or malignant tumor(s)

研究者

发起方
niversitätsklinikum Heidelberg

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