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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00393692
Enrollment
700
Registered
2006-10-30
Start date
2000-08-31
Completion date
2018-10-31
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

Keywords

Age-related macular degeneration, Geographic atrophy, drusen

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.

Interventions

None listed

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change of geographic atrophy size to baseline36 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026