EUCTR2016-003870-41-ES进行中（未招募）1 期
Comparison of treatment of diabetic macular edema with Ozurdex® versus Ozurdex® plus laser in areas of peripheral non-perfusion
Fundación para la Investigación Biomédica del Hospital Universitario Príncipe de Asturias0 个研究点目标入组 30 人开始时间: 2017年1月5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
- 30
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
- •Patients with clinically significant diabetic macular edema with new diagnosis and peripheral ischemia
- •AVMC between 23 and 75 letters
- •Pseudophakic
- •Over 18 years
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Previous history of glaucoma.
- •Previous history of herpes eye infection.
- •Prior history of vitrectomy.
- •Previous therapeutic radiation near the eye region of the study
- •Impossibility to perform fluorescein angiography.
- •Inability to sign informed consent.
- •Participation in a study with a research drug, biological product, or device within 30 days or duration of 5 half-lives of the investigational product (whichever is longer) prior to the start of the study Note: Studies that involve only over-the-counter vitamins, supplements, or diets are not included.
- •Background of a medical disorder (disease, metabolic dysfunction, physical examination finding, clinical analytical finding) that, according to the investigator's opinion, would prevent scheduled study visits, study completion, or safe administration of the product under investigation.
- •Any antecedent or evidence of concurrent intraocular disease in the eye of the study, such as retinal diseases other than EMD that, in the investigator's judgment, may require medical or surgical intervention during the course of the study to prevent or treat loss of acuity visual impairment that could result from that disease, or that limits the potential for visual acuity gain with treatment with the investigational product
研究者
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