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临床试验/NCT00393692
NCT00393692已完成不适用

Prospective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy

University Hospital, Bonn7 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2000年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
试验地点
7
主要终点
Change of geographic atrophy size to baseline

研究概览

简要总结

The purpose of this study is to define phenotypic variations in atrophic Age-Related Macular Degeneration (AMD) and to identify predictive factors for disease progression based on fundus autofluorescence imaging.

详细描述

Age-related macular degeneration (AMD) is the leading cause of legal blindness in the industrialized world beyond 50 years of age. Ageing changes of the retinal pigment epithelium (RPE) play a key role in the pathogenesis of the disease. In postmitotic RPE cells autofluorescent lipofuscin granules accumulate with age in the lysosomal compartment mainly as a byproduct of constant phagocytosis of membranous disks shed from photoreceptor outer segments. With the advent of confocal scanning laser ophthalmoscopy fundus autofluorescence mediated by RPE-lipofuscin accumulation can be visualized in vivo: We plan to identify fundus autofluorescence changes as predictive factors for the development of late stage manifestations and their variation over time. Furthermore, we plan to determine the effect of increased focal accumulations of autofluorescent material on retinal sensitivity using fundus perimetry. Examination of human donor eyes with AMD will allow for correlation of fundus autofluorescence alterations in vivo and in vitro. These investigations will be performed not only to better understand the role of lipofuscin accumulation in AMD but also to manipulate these mechanisms for both experimental and therapeutic ends.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Must be considered reliable, willing and able to give informed consent.
  • Age >50 years (male or female)
  • Must have age-related macular degeneration in at least one eye
  • Clear media to allow imaging

排除标准

  • any history of retinal surgery, including laser treatment, photodynamic therapy, radiation or intravitreal injections
  • history of retinal vascular occlusions
  • any concurrent intraocular condition that, in the opinion of the investigator, could exclude the patient from the medical or ethical point of view

结局指标

主要结局

Change of geographic atrophy size to baseline

时间窗: 36 months

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank G. Holz

Prof. Dr. med.

University Hospital, Bonn

研究点 (7)

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