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临床试验/NCT02521142
NCT02521142招募中不适用

Non-invasive Optical Angiography in Age-related Macular Degeneration

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
1
主要终点
Differences in visualization of lesion size between non-invasive OCT based optical angiography and FLA/ICG angiography in treatment-naïve and treated patients with CNV due to AMD.

研究概览

简要总结

Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. There is now convincing evidence that vascular endothelial growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of AMD. Today, the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with active CNV due to AMD as assessed by FLA/ICG angiography within 1 week prior to study inclusion
  • Exclusion criteria
  • Any of the following will exclude a patient from the study:
  • Previous application of intravitreal drugs except anti-VEGF injections
  • Active intraocular inflammation
  • Presence of an intraocular disease except AMD and cataract

排除标准

  • 未提供

结局指标

主要结局

Differences in visualization of lesion size between non-invasive OCT based optical angiography and FLA/ICG angiography in treatment-naïve and treated patients with CNV due to AMD.

时间窗: Participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days

次要结局

  • choroidal thickness as assessed with OCT(participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days)
  • peripapillarly bloodflow as assessed with Doppler OCT(participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Sacu

Prof. Dr.

Medical University of Vienna

研究点 (1)

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