ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00393692
Recruitment Status : Active, not recruiting
First Posted : October 30, 2006
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Frank G. Holz, 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.

Condition or disease
Age-related Macular Degeneration

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 Type : Observational
Actual Enrollment : 700 participants
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
Study Start Date : August 2000
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change of geographic atrophy size to baseline [ Time Frame: 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:

Other 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
First Posted: October 30, 2006    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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