EUCTR2009-017540-13-GB进行中（未招募）不适用
A Phase IV Open-Labelled Prospective Pilot Study of Intravitreal Macugen (pegaptanib) for Ischaemic Diabetic Macular Oedema (MIDME study) - Intravitreal Macugen for Ischaemic Diabetic Macular Oedema
Clinical Trials and Research Governance0 个研究点目标入组 30 人开始时间: 2010年8月5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
- 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
- 性别
- All
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •BCVA 20/32 to 20/320 inclusive
- •Central OCT thickness > 300 microns
- •Enlargement of FAZ (ischaemia or capillary drop out of >30% on FFA)
- •Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- •Able (in the Investigator's opinion) and willing to comply with all study requirements e.g. attending for tests and treatment every 6 weeks.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- •Any significant disease or disorder, e.g. recent stroke or myocardial infarction, which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
- •Participants who have participated in another research study involving an investigational product in the past 12 weeks
- •Laser within 3 months
- •Intraocular surgery within 6 months
- •Known allergy to Macugen (pegaptanib)
- •Known allergy to fluorescein
研究者
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