跳至主要内容
临床试验/EUCTR2014-001047-21-SE
EUCTR2014-001047-21-SE进行中(未招募)不适用

Randomized trial comparing injection frequency between Aflibercept and Ranibizumab in patients with Central Retinal Vein Occlusion with a treat and extent algorithm

Sankt Eriks Eye Hospital0 个研究点开始时间: 2014年4月11日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • CRVO - naive patients
  • CRVO with a maximum duration of 12 months
  • Fertile women: Negative pregnancy test and use of contraceptive 3 months after last treatment
  • BCVA : ETDRS 23-73 letters (20/40 – 20/320)
  • Macular edema > 300 µm (Cirrus)
  • 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 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • CRVO with neovascularization
  • Any previous treatment for CRVO.
  • Intraocular surgery during the previous 3 months.
  • Vascular retinopathy of other causes.
  • Active ocular infection or inflammation.
  • Myocardial infarction or stroke during the last 3 months.
  • Sensitivity to aflibercept or one of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose, Water for injection
  • Sensitivity to ranbizumab or one of the excipients (Trehalose dihydrate, histidine hydrochloride monohydrate, histidine, polysorbate 20, water for injections)

研究者

发起方
Sankt Eriks Eye Hospital

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