Fundus Autofluorescence Imaging in Age-related Macular Degeneration Using Confocal Scanning Laser Ophthalmoscopy

Completed

• Conditions: Age-related Macular Degeneration

• Registration Number: NCT00393692
• Lead Sponsor: University Hospital, Bonn

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2006-10-26
• Study First Submitted QC: 2006-10-26
• Study First Posted: 2006-10-29
• Primary Completion: 2016-04
• Status Verified: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of geographic atrophy size to baseline	36 months

Trial Locations

Locations (7)

Institute for Medical Statistics and Biometry, University of Heidelberg; 🇩🇪 Heidelberg, Germany

Department of Ophthalmology, University of Heidelberg; 🇩🇪 Heidelberg, Germany

Department of Ophthalmology, University of Leipzig; 🇩🇪 Leipzig, Germany

Department of Ophthalmology, University of Aachen; 🇩🇪 Aachen, Germany

• Institute for Biometry and Epidemiology, Ludwig-Maximilians-University; 🇩🇪 Munich, Germany

St. Franziskus Hospital Münster; 🇩🇪 Münster, Germany

Department of Ophthalmology, University of Würzburg; 🇩🇪 Würzburg, Germany