EUCTR2014-001640-38-FR进行中（未招募）不适用
Efficacy of Aflibercept (Eylea®) on Type 3 choroidal neovascularization. - ATTRACT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •-Males or females aged more than 50 years
- •-Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
- •oThe type 3 CNV will be defined by following chacteristics on ICG: early hyperfluorescence spot at the end of a branching retinal vessel in the macular area frequently associated with punctiform retinal hemorrhage and hot spot on late frames sometimes located in an area of hypofluorescence due to pigment epithelium detachment.
- •oThe type 3 CNV will be defined by following chacteristics on OCT: Effraction of the RPE layer toward the neurosensory retina, associated with exudation within or under the retina. This typical lesion will be observed when OCT scans located on hot spots.
- •-Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS letter score) in the study eye (approximately between 20/320 and 20/32 Snellen equivalent)
- •-Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
- •-Ability to read, understand the study procedures
- •-Given written informed consent allowing participation to this 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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •-Any contraindications as reported in the labelling of Eylea®: Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity in the study eye
- •-Any previous history of intravitreal injections in the study eye for exudative AMD in the study eye
- •-Any secondary chorioretinal anastomosis due to retinal scar or fibrosis in the study eye
- •-Any history of vitrectomy in the study eye
- •-Media opacities preventing accurate imaging of the retina (cataract) in the study eye
- •-Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole) in the study eye
- •-Intellectual deficiency
- •-Any active infectious disease
- •-Patients with a significant medical condition which may interfere with the evaluation of safety or efficacy of the study compound (e.g., myocardial infarction, unstable angina pectoris within 3 months prior to study inclusion, severe renal failure or patients with renal dialysis / renal transplant).
- •-Confirmed intraocular pressure =25 mmHg or non-stable glaucoma in the study eye
研究者
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