EUCTR2014-005556-25-ES进行中（未招募）1 期
Open extension study for patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulatedcontrolled treatment to evaluate safety and efficacy of intravitreal etamsilato code OFT-ETAMSILATO -4.2.1
Investigacion Independiente0 个研究点目标入组 44 人开始时间: 2015年2月17日最近更新:
适应症
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 diagnosed of dry or wet ARMD, who completed the clinical trial with protocol code OFT-ethamsylate-4.2.1
- •-Able and in agreement to follow the study protocol and to give the inform consent.
- •Inclusion criteria to provide treatment with intravitreal ethamsylate in the same treated eye in the clinical trial:
- •-Patients who show no response to treatment (lose 15 or more letters in the ETDRS chart) in the treated eye in the trial between weeks 4 and 16 after administration of the double-blinded treatment.
- •-Based on investigator judgment is the most appropriate treatment option.
- •Inclusion criteria to provide treatment with intravitreal ethamsylate in the contralateral eye:
- •- Patients who show treatment response (lost 14 or fewer letters in the ETDRS chart) in the treated eye in the clinical trial at 16 weeks
- •-The contralateral eye (untreated in the clinical trial) has a dry or wet ARMD, diagnosed later than the previous two years
- •-Grade 5 ARMD.
- •-The best visual acuity correted between 20/25 and 20/320, evaluated with optotype ETDRS
- •-Not present any ocular pathology, based on investigator judgment could interfere in the development, evolution and evaluation of ARMD as glaucoma, permanent structural damage in central foveal, parafoveolar geographic atrophy, choroidal vasculopathy Polypoidal, so on.
- •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-
- •-Patients at week 16 of the previous clinical trial show treatment response (losing 14 or Afewer letters in the ETDRS chart) in the treated eye, only a non-interventionist track that eye will be performed until week 48 after treatment delivery.
研究者
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