NCT03370380已完成不适用
Intravitreal Aflibercept in Patients With Retinal Pigment Epithelial Detachment (PED) Secondary to Age Related Macular Degeneration (AMD)
University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年4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
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Retention and improvement of visual acuity
研究概览
简要总结
Uncontrolled single site non randomized non interventional study to determine the safety and efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to retinal pigment epithelial detachment secondary to AMD
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with vascular PED due to AMD
- •Male or female patients with the age > 50 years
- •Angiographic and via OCT ensured PED ≥ 200 µm in the eye for treatment
- •Written informed consent
- •Best corrected visual acuity (ETDRS-Visus): 24 - 73 letters within
排除标准
- •Patients that do not fulfill the a. m. inclusion criteria
- •Patients which have been treated with steroids or with verteporfin via photodynamic therapy or focal lasercoagulation treatment until 3 months before,
- •Anti VEGF therapy until 1 month before screening
- •Patients with other retinal vascular diseases including diabetic rethinopathia or retinal vein occlusion
- •Other ocular operative procedurs 3 months before Screening
- •Anamnesis of non controlled glaucoma
- •Active or intraocular Inflammation or Inflammation of ocular adnexa
- •Subfoveal fibrosis within study eye
- •Larger surgical interventions 1 month before Screening
- •Anamnesis of serious cardiovascular diseases or stroke 6 months before srceening
- •Allergy of components of the study medication
- •Patients which might be not compliant
- •Patients participating at another clinical trial at the same time
- •Pregnancy, breastfeeding, women in child-bearing years without using a safe contraception method
- •Chronical alcohol- or drug abuse within the last year
- •lack of capacity and/or knowledge of German language
- •Neurologic disease i. e. multiple sclerosis
结局指标
主要结局
Retention and improvement of visual acuity
时间窗: Screening until 1 month after last injection within study eye (Month 12)
Visual acuity after treatment completion compared to baseline
Height of Pigment Epithel Detachment
时间窗: Screening until 1 month after last injection within study eye (Month 12)
The height of PED after treatment completion compared to baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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