NCT02537054已完成2 期
Intravitreal Aflibercept (Eylea) for Therapy of Choroidal Neovascularization (CNV) and Fibrovascular Proliferation (FVP) in Patients With Pseudoxanthoma Elasticum (PXE)
University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in distance best corrected visual acuity between end-of study visit and screening visit
研究概览
简要总结
The purpose of this study is to determine whether Aflibercept (Eylea) is effective in the treatment of choroidal neovascularization and fibrovascular proliferation in patients with pseudoxanthoma elasticum (PXE) in terms of preservation or improvement of visual acuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PXE by moleculargenetic diagnosis and/or skin biopsy
- •Diagnosed CNV or FVP
- •Age 18-65 years
- •Voluntary participation in this study as proven by written informed consent
- •Ability to follow study instructions and likely to attend and complete all required visits
- •Best corrected visual acuity between 20/400 and 20/20 at treated eye
- •Male and female patients with childbearing potential must use an approved contraceptive method (Pearl Index < 1) before and during the trial
- •Pre-menopausal female patients with childbearing potential: a negative pregnancy test must be obtained
排除标准
- •Subject is unable to understand the nature, scope, significance and consequences of this clinical trial
- •Patients with known allergy or hypersensitivity to Eylea or preparations with similar chemical structure
- •Treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial of within 30 days before enrolment
- •Known or persistent abuse of medication, drugs or alcohol
- •Women who are pregnant or breast feeding
- •Lack of eligibility at discretion of the investigator
- •Ocular operations within a month prior to enrolment
- •Non-controlled glaucoma
- •Active intraocular inflammation or inflammation of ocular adnexa
- •Other diseases resulting in distinct visual constraint
- •Distinct opacification of optical media
- •Distinct subretinal fibrosis and /or atrophy that prevents a relevant treatment effect by Aflibercept at discretion of investigator
- •Serious cardiovascular problems or stroke within 6 months before enrolment
- •Simultaneous use of other Vascular Endothelial Growth Factor (VEGF)-inhibiting medication (systemic or ocular) within a month prior to enrolment
研究组 & 干预措施
Aflibercept
Experimental
2 mg/ dose (pro re nata, maximum 1 dose/ month), intravitreal use
干预措施: Aflibercept (Drug)
结局指标
主要结局
Change in distance best corrected visual acuity between end-of study visit and screening visit
时间窗: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)
次要结局
- Change in light increment sensitivity of central visual field between end-of study visit and screening visit measured by microperimetry(Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7))
- Change in chorioretinal neovascularization and leakage measured by angiography between end-of study visit and screening visit(Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7))
- Change in sub- and intraretinal und subpigmentepithelial fluids assessed using optical coherence tomography (OCT)(Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7))
- Extent of fibrovascular proliferation on optical coherence tomography (OCT) imaging(Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7))
- Changes fundus autofluorescence images using a confocal scanning laser ophthalmoscope (cSLO)(Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7))
- Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(12 months)
- Change in the health status of the total population measured by quality of life questionnaire Visual Function Questionnaire (VFQ)-25(Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7))
研究者
Frank G. Holz
Prof. Dr. med. Frank G. Holz
University Hospital, Bonn
研究点 (1)
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