Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Eye Diseases+2

+ Macular Degeneration

+ Retinal Degeneration

Over 50 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2000
See protocol details

Summary

Principal SponsorUniversity Hospital, Bonn
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2000

Actual date on which the first participant was enrolled.

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.

Official TitleProspective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy
NCT00393692
Principal SponsorUniversity Hospital, Bonn
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

700 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesGeographic Atrophy

Criteria

4 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Department of Ophthalmology, University of Aachen

Aachen, GermanyOpen Department of Ophthalmology, University of Aachen in Google Maps
Suspended

Department of Ophthalmology, University of Heidelberg

Heidelberg, Germany
Suspended

Institute for Medical Statistics and Biometry, University of Heidelberg

Heidelberg, Germany
Suspended

Department of Ophthalmology, University of Leipzig

Leipzig, Germany
Completed7 Study Centers