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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital, Bonn
Information provided by (Responsible Party):
Frank G. Holz, University Hospital, Bonn Identifier:
First received: October 26, 2006
Last updated: December 2, 2014
Last verified: December 2014
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.

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 ]

Estimated Enrollment: 300
Study Start Date: August 2000
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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.

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00393692

Contact: Frank G Holz, MD +4922828715647
Contact: Steffen Schmitz-Valckenberg, MD +4922828715808

Department of Ophthalmology, University of Aachen Recruiting
Aachen, Germany, 52074
Contact: Andreas W Weinberger, MD    +49 241 80 88191   
Sub-Investigator: Andreas W Weinberger, MD         
Principal Investigator: Peter Walter, MD         
Department of Ophthalmology, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Matthias Becker, MD    +496221566695   
Contact: Friderike Mackensen, MD    +496221566695   
Principal Investigator: Matthias Becker, MD         
Institute for Medical Statistics and Biometry, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Jens Dreyhaupt, MD    +496221564180   
Principal Investigator: Jens Dreyhaupt, PhD         
Department of Ophthalmology, University of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Christian Foja, MD    +493419721650   
Contact: Andreas Moessner, MD    +493419721650   
Principal Investigator: Peter Wiedemann, MD         
Sub-Investigator: Christian Foja, MD         
Sub-Investigator: Sebastian Wolf, MD, PhD         
• Institute for Biometry and Epidemiology, Ludwig-Maximilians-University Recruiting
Munich, Germany, 81377
Contact: Ulrich Mansmann, PhD    +49 89 7095 4494   
Principal Investigator: Ulrich Mansmann, PhD         
St. Franziskus Hospital Münster Recruiting
Münster, Germany, 48145
Contact: Daniel Pauleikhoff, MD    +49251933080   
Contact: Georg Spital, MD    +49251933080   
Principal Investigator: Daniel Pauleikhoff, MD         
Sub-Investigator: Georg Spital, MD         
Department of Ophthalmology, University of Würzburg Recruiting
Würzburg, Germany, 97080
Contact: Claudia Keilhauer, MD    +4993120120388   
Principal Investigator: Claudia Keilhauer, MD         
Sponsors and Collaborators
University Hospital, Bonn
Principal Investigator: Frank G Holz, MD University of Bonn
  More Information

Additional Information:

Additional publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Frank G. Holz, Prof. Dr. med., University Hospital, Bonn 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: December 2, 2014
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases processed this record on February 07, 2016