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临床试验/EUCTR2015-001812-36-ES
EUCTR2015-001812-36-ES进行中(未招募)1 期

Extension study for the follow up of patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulated controlled treatment to evaluate safety and efficacy of intravitreal etamsilato code OFT-ETAMSILATO -4.2.1

Dr. Pedro Cuevas Sanchez (Investigacion Independiente)0 个研究点目标入组 44 人开始时间: 2015年6月15日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
44

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

  • -Patients who show response to treatment (lose 15 or more letters in the ETDRS chart) in the treated eyeat week 16 after administration of the double-blinded treatment.
  • -Able and in agreement to follow the study protocol and to give the inform consent.
  • 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 80
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 80

排除标准

  • -Patients with concomitant illness that, based on the investigator judgment, could interfere (due to the disease itself or due to the associate treatment) in the development, evolution or evaluation of the ARMD, as diabetes mellitus with ocular affectation, active or ongoing systemic infection, any other ocular infection, psychiatric alterations, social situation, which could interfere in the compliance with the study requirements and so on.
  • -Pregnant or breast-feeding

研究者

发起方
Dr. Pedro Cuevas Sanchez (Investigacion Independiente)

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