EUCTR2017-003899-31-PT进行中（未招募）1 期
International, multicenter, randomised, double-blind, sham-controlled, 2x2 cross over phase III clinical trial to assess the efficacy and security of an intravitreal injection of Etamsylate in the improvement of visual acuity of patients with dry age-related macular degeneration. - JERICHO_D
DOBECURE, S.0 个研究点目标入组 60 人开始时间: 2018年7月27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
- 60
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
入选标准
- •Adult patients, aged =18 years, males or females.
- •Diagnosis of dry AMD
- •Patients with best corrected visual acuity (BCVA) between 20/25 and 20/320, measured by ETDRS optotype (Early Treatment Diabetic Retinopathy Study)
- •Women of childbearing potential (defined as a premenopausal female capable of becoming pregnant) should be willing to follow and use the following highly effective contraconceptive methods:
- •-Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
- •-progestogen-only hormonal contraception associated with inhibition of
- •-Ovulation (oral, injectable or implantable)
- •-intrauterine device (IUD)
- •-intrauterine hormone-releasing system (IUS)
- •-bilateral tubal occlusion
- •-vasectomised partner
- •-sexual abstinence
- •-postmenopausal women (defined as women that have had their last menstruation at least 12 months before study inclusion).
- •Patients with the capacity and disposition to follow the study protocol and procedures and that grant their informed consent in writing (signed and dated), accepting voluntarily to participate in the trial
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Patients with grade 5 AMD in one or both eyes.
- •Patients with any concomitant ocular disease that, under investigator’s judgement, could influence the development, evaluation or assessment of the AMD, such as glaucoma, permanent structural damage in the centre of the fovea, Geographic parafoveolar atrophy, Polypoid choroidal vasculopathy etc.
- •Patients with ocular or periocular infection.
- •Patients with any concomitant disease that, under investigator’s judgement, could influence (the disease itself or its treatment) the development, evaluation or assessment of the AMD, such as diabetes mellitus with ocular affectation, current or active systemic infection, any ocular infection, psychiatric diseases, social situation that may affect study protocol compliance etc.
- •Patients treated with any intravitreal anti-VEGF agent or other intravitreal drug such as corticosteroids within the last month prior to study randomisation entry
- •Pregnant or breastfeeding women (urine pregnancy test to be performed for those patients of childbearing potential patients)
- •Hyper sensibility to etamsylate or any of the excipients contained in the form used for the trial.
- •Patients with any of the contraindicated diseases described in the SMPC of Dycinone, such us but not limited to: porphyria, bleeding caused by treatment with anticoagulants, fibrosis/benign tumours in the uterus and patients with a recent history of stroke.
- •Patients that have participated in Dry-AMD clinical trials with intervention (observational, epidemiologic or economic studies are allowed).
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