EUCTR2013-005081-19-FR进行中（未招募）不适用
Phase II study evaluating the efficacy of aflibercept for the treatment of idiopathic choroidal neovascularization in young subjects: the INTUITION study - INTUITIO
HOSPICES CIVILS DELYO0 个研究点开始时间: 2015年6月17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
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 between 18 and 50 years;
- •- Patient has given and signed free informed consent
- •- Patient affiliated to a social security or equivalent;
- •- Patient suffering from idiopathic choroidal neovascularization lesions with active subfoveal, or juxtafoveal primary location affecting the fovea, demonstrated by angiography (fluorescein and / or indocyanine green) and / or OTC;
- •- Patient willing and able to return to all clinical study visits and perform all procedures.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant women;
- •- Male or female of childbearing age , sexually active, who do not want to commit to use a means of adequate contraception during the study;
- •- Patient protected under the terms of the law ( Code of Public Health ) ;
- •- Participation of the patient to another clinical trial ( study eye and / or eye not studied ) ;
- •- Patient suffering from non idiopathic choroidal neovascularizationnot , especially
- •- Patient with AMD ;
- •- Patient with high myopia defined by refraction = -6 diopters ;
- •- Other curative treatment of idiopathic choroidal neovascularization in the study eye within 3 months before the first intravitreal injection : anti -VEGF therapy, macular laser juxta- or extra- foveal , PDT , surgery, external radiotherapy, transpupillary thermotherapy ...
- •- History focal macular laser photocoagulation of subfoveal the study eye ;
- •- Presence of a subretinal hemorrhage reaching the center of the fovea , size of = 50 % of the surface of the lesion ;
- •- Subfoveal fibrosis or retinal atrophy of the study eye ;
- •- Tear of the retinal pigmented epithelium reaching the macula of the eye studied .
- •- History of intravitreal devices in the study eye ;
- •- History of autoimmune or idiopathic uveitis ;
- •- Diabetic retinopathy proved ;
- •- Intraocular pressure > 25 mmHg despite two treatments antiglaucoma eye drops ;
- •- Aphakia or absence of posterior capsule (other than Yag laser capsulotomy ) in the study eye ;
- •- Uncontrolled hypertension by appropriate treatment ;
- •- History of treatment or ongoing treatment with systemic anti -VEGF;
- •- Hypersensitivity to the active substance or to any of the excipients ; , known fluorescein, indocyanine green and anesthetic eye drops allergy
- •- Eye infection or active or suspected periocular ;
- •- Severe intraocular inflammation active ;
- •- Intraocular surgery within 28 days before the first intravitreal injection in the study eye ;
- •- Any eye disease or condition of the eye studied by the investigator might need an intraocular surgery within 12 months ;
- •- 12 months Follow-up impossible
研究者
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