This trial is active, not recruiting.

Condition age-related macular degeneration
Sponsor University Hospital, Bonn
Start date August 2000
End date April 2016
Trial size 700 participants
Trial identifier NCT00393692, DFG Priority Program AMD, FAM-Study, Ho 1926/1-3, Ho 1926/3-1, Ma 1723/1-1, SPP 1088


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Change of geographic atrophy size to baseline
time frame: 36 months

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Prospective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy
Principal investigator Frank G Holz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University Hospital, Bonn.