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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Frank G. Holz, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00393692
First received: October 26, 2006
Last updated: April 25, 2016
Last verified: April 2016
  Purpose
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.

Condition
Age-related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Change of geographic atrophy size to baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 700
Study Start Date: August 2000
Estimated Study Completion Date: January 2019
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with unilateral or bilateral geographic atrophy due to AMD, aged 50 years and older. German population
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00393692

Locations
Germany
Department of Ophthalmology, University of Aachen
Aachen, Germany, 52074
Department of Ophthalmology, University of Heidelberg
Heidelberg, Germany, 69120
Institute for Medical Statistics and Biometry, University of Heidelberg
Heidelberg, Germany, 69120
Department of Ophthalmology, University of Leipzig
Leipzig, Germany, 04103
• Institute for Biometry and Epidemiology, Ludwig-Maximilians-University
Munich, Germany, 81377
St. Franziskus Hospital Münster
Münster, Germany, 48145
Department of Ophthalmology, University of Würzburg
Würzburg, Germany, 97080
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Frank G Holz, MD University of Bonn
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Frank G. Holz, Prof. Dr. med., University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00393692     History of Changes
Other Study ID Numbers: FAM-Study  DFG Priority Program AMD  SPP 1088  Ho 1926/1-3  Ho 1926/3-1  Ma 1723/1-1 
Study First Received: October 26, 2006
Last Updated: April 25, 2016
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
Age-related macular degeneration
Geographic atrophy
drusen

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 26, 2016