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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Frank G. Holz, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00393692
First received: October 26, 2006
Last updated: June 13, 2012
Last verified: June 2012
  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:

Estimated Enrollment: 300
Study Start Date: August 2000
Estimated Study Completion Date: October 2012
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
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 ClinicalTrials.gov identifier: NCT00393692

Contacts
Contact: Frank G Holz, MD +4922828715647 frank.holz@ukb.uni-bonn.de
Contact: Steffen Schmitz-Valckenberg, MD +4922828715808 steffen.schmitz-valckenberg@ukb.uni-bonn.de

Locations
Germany
Department of Ophthalmology, University of Aachen Recruiting
Aachen, Germany, 52074
Contact: Andreas W Weinberger, MD    +49 241 80 88191    aweinberger@ukaachen.de   
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    matthias_becker@med.uni-heidelberg.de   
Contact: Friderike Mackensen, MD    +496221566695    Friderike_Mackensen@med.uni-heidelberg.de   
Principal Investigator: Matthias Becker, MD         
Institute for Medical Statistics and Biometry, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Jens Dreyhaupt, MD    +496221564180    dreyhaupt@imbi.uni-heidelberg.de   
Principal Investigator: Jens Dreyhaupt, PhD         
Department of Ophthalmology, University of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Christian Foja, MD    +493419721650    christian.foja@medizin.uni-leipzig.de   
Contact: Andreas Moessner, MD    +493419721650    andreas.moessner@medizin.uni-leipzig.de   
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    mansmann@ibe.med.uni-muenchen.de   
Principal Investigator: Ulrich Mansmann, PhD         
St. Franziskus Hospital Münster Recruiting
Münster, Germany, 48145
Contact: Daniel Pauleikhoff, MD    +49251933080    kpl-auge@muenster.de   
Contact: Georg Spital, MD    +49251933080    kpl-auge@muenster.de   
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    c.keilhauer@yahoo.com   
Principal Investigator: Claudia Keilhauer, MD         
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Frank G Holz, MD University of Bonn
  More Information

Additional Information:
Publications:

Additional 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: June 13, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 20, 2014