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临床试验/CTRI/2017/09/009699
CTRI/2017/09/009699已完成3 期

First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial - FAST

Proctor Foundation University of California0 个研究点目标入组 130 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
130

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1) Historical non-infectious intermediate, anterior and intermediate, posterior or panuveitis in at least one eye
  • 2) Active inflammation within the last 180 days, defined by the presence of any of the following (in at least one eye) according to SUN criteria:
  • a) >= 2+ anterior chamber cells
  • b) >= 2+ vitreous haze
  • c) active retinal or choroidal lesions
  • 3) Active inflammation at enrollment, defined by the presence of any of the following (in at least one eye) according to SUN criteria:
  • a) >=1+ anterior chamber cells and/or
  • b) >=1+ vitreous haze and/or
  • c) active retinal/choroidal lesions

排除标准

  • 1) Any infectious cause of uveitis
  • 2) Prior immunosuppressive therapy other than corticosteroids in the past 12 months
  • 3) Prior intolerability or safety issues with methotrexate or mycophenolate mofetil
  • 4) Prior failure to control ocular or other inflammation using methotrexate or mycophenolate mofetil
  • 5) Prior biologic therapy at any time
  • 6) Media opacity (such as cataract and/or corneal scar) and/or extensive posterior synechiae such that examination of the posterior segment is not possible in both eyes
  • 7) Chronic hypotony (IOP < 5 mm Hg for > 3 months) in both eyes
  • 8) Periocular or intravitreal corticosteroid injection in the past 4 weeks
  • 9) Fluocinolone acetonide implant in either eye in < 3 years
  • 10) Intraocular surgery in < 30 days, or planning on getting surgery within the next 6 months
  • 11) Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye
  • < 16 years of age at enrollment

研究者

发起方
Proctor Foundation University of California

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