EUCTR2016-001660-10-AT进行中（未招募）1 期
Influence of aflibercept (Eylea) on macular perfusion in patients with macular edema secondary to retinal vein occlusion
niversitätsklinik für Augenheilkunde und Optometrie0 个研究点目标入组 30 人开始时间: 2018年10月25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
- 性别
- All
入选标准
- •Male or female, at least 18 years of age.
- •Ophthalmoscopic evidence of recent BRVO or CRVO (i.e. a history of 3 months or less).
- •Macular edema secondary to BRVO or CRVO in the study eye sheduled for intravittreal Eylea®.
- •Retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline.
- •VA decrease attributable to the edema.
- •Written informed consent has been obtained.
- •Female patients of childbearing potential must have a negative urine pregnancy test.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Any of the following will exclude a subject from the study:
- •Uncontrolled systemic disease
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •History of glaucoma, aphakia or presence of anterior chamber intraocular lens, active retinal neovascularization, choroidal neovascularization, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study period.
- •Contraindication to pupil dilation, known allergy, or contraindication to the use of fluorescein.
- •Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
- •Active or suspected ocular or periocular infection in the study eye.
- •Active intraocular inflammation (grade trace or above) in the study eye.
- •Any active infection involving eyeball adnexa
- •Pregnant or breast-feeding women.
- •Women of childbearing potential with either a positive pregnancy test result or no
- •pregnancy test at baseline are excluded. Postmenopausal women must be amenorrheic
- •for at least 12 months in order not to be considered of child bearing potential.
- •Sexually active men or women of childbearing potential who are unwilling to practice
- •adequate contraception during the study are excluded. (adequate contraceptive
- •measures include stable use of oral contraceptives or other prescription
- •pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening;
- •intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus
- •contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or
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