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|Status||Condition||Sponsor/Collaborator(s)||First Received||Last Changed||Verification Date|
|Recruiting||Age-related Macular Degeneration||University Hospital, Bonn Other||October 26, 2006||June 13, 2012||June 2012|
|Study Type||Study Design||Phase||Enrollment||Start Date||End Date|
|Observational||Observational Model: Cohort, Time Perspective: Prospective||N/A||300||August 2000||-|
|Department of Ophthalmology, University of Aachen||Aachen 52074 Germany||Andreas W Weinberger, MDfirstname.lastname@example.org||Recruiting|
|Department of Ophthalmology, University of Heidelberg||Heidelberg 69120 Germany||Matthias Becker, MDemail@example.com||Recruiting|
|Institute for Medical Statistics and Biometry, University of Heidelberg||Heidelberg 69120 Germany||Jens Dreyhaupt, MDfirstname.lastname@example.org||Recruiting|
|Department of Ophthalmology, University of Leipzig||Leipzig 04103 Germany||Christian Foja, MDemail@example.com||Recruiting|
|• Institute for Biometry and Epidemiology, Ludwig-Maximilians-University||Munich 81377 Germany||Ulrich Mansmann, PhDfirstname.lastname@example.org||Recruiting|
|St. Franziskus Hospital Münster||Münster 48145 Germany||Daniel Pauleikhoff, MDemail@example.com||Recruiting|
|Department of Ophthalmology, University of Würzburg||Würzburg 97080 Germany||Claudia Keilhauer, MDfirstname.lastname@example.org||Recruiting|
Prospective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy
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
|Gender||Minimum Age||Maximum Age||Healthy Volunteers|
|Both||-||N/A||Accepts Healthy Volunteers|
- 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
- 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
PMID 9987631: Holz FG, Bellmann C, Margaritidis M, Schutt F, Otto TP, Volcker HE. Patterns of increased in vivo fundus autofluorescence in the junctional zone of geographic atrophy of the retinal pigment epithelium associated with age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 1999 Feb;237(2):145-52.
PMID 11274085: Holz FG, Bellman C, Staudt S, Schutt F, Volcker HE. Fundus autofluorescence and development of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2001 Apr;42(5):1051-6.
PMID 19171212: Schmitz-Valckenberg S, Fleckenstein M, Scholl HP, Holz FG. Fundus Autofluorescence and Progression of Age-related Macular Degeneration. Surv Ophthalmol. 2009 Jan-Feb;54(1):96-117.
PMID 18852430: Fleckenstein M, Charbel Issa P, Helb HM, Schmitz-Valckenberg S, Scholl HP, Holz FG. Correlation of lines of increased autofluorescence in macular dystrophy and pigmented paravenous retinochoroidal atrophy by optical coherence tomography. Arch Ophthalmol. 2008 Oct;126(10):1461-3. No abstract available.
PMID 18514607: Schmitz-Valckenberg S, Fleckenstein M, Göbel AP, Sehmi K, Fitzke FW, Holz FG, Tufail A. Evaluation of autofluorescence imaging with the scanning laser ophthalmoscope and the fundus camera in age-related geographic atrophy. Am J Ophthalmol. 2008 Aug;146(2):183-92. Epub 2008 Jun 2.