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

Age-related Macular Degeneration Clinical Trial

Official title:

Prospective Natural History Study of Fundus Autofluorescence Imaging in Age-related Macular Degeneration (FAM-Study) Using Confocal Scanning Laser Ophthalmoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393692
• Other study ID #: FAM-Study
• Secondary ID: DFG Priority Pro
• Status: Completed
• Start date: August 2000
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University of Aachen	Aachen
Germany	Department of Ophthalmology, University of Heidelberg	Heidelberg
Germany	Institute for Medical Statistics and Biometry, University of Heidelberg	Heidelberg
Germany	Department of Ophthalmology, University of Leipzig	Leipzig
Germany	• Institute for Biometry and Epidemiology, Ludwig-Maximilians-University	Munich
Germany	St. Franziskus Hospital Münster	Münster
Germany	Department of Ophthalmology, University of Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (14)

Bellmann C, Jorzik J, Spital G, Unnebrink K, Pauleikhoff D, Holz FG. Symmetry of bilateral lesions in geographic atrophy in patients with age-related macular degeneration. Arch Ophthalmol. 2002 May;120(5):579-84. — View Citation

Bindewald A, Bird AC, Dandekar SS, Dolar-Szczasny J, Dreyhaupt J, Fitzke FW, Einbock W, Holz FG, Jorzik JJ, Keilhauer C, Lois N, Mlynski J, Pauleikhoff D, Staurenghi G, Wolf S. Classification of fundus autofluorescence patterns in early age-related macula — View Citation

Bindewald A, Schmitz-Valckenberg S, Jorzik JJ, Dolar-Szczasny J, Sieber H, Keilhauer C, Weinberger AW, Dithmar S, Pauleikhoff D, Mansmann U, Wolf S, Holz FG. Classification of abnormal fundus autofluorescence patterns in the junctional zone of geographic — View Citation

Deckert A, Schmitz-Valckenberg S, Jorzik J, Bindewald A, Holz FG, Mansmann U. Automated analysis of digital fundus autofluorescence images of geographic atrophy in advanced age-related macular degeneration using confocal scanning laser ophthalmoscopy (cSL — View Citation

Dreyhaupt J, Mansmann U, Pritsch M, Dolar-Szczasny J, Bindewald A, Holz FG. Modelling the natural history of geographic atrophy in patients with age-related macular degeneration. Ophthalmic Epidemiol. 2005 Dec;12(6):353-62. — View Citation

Einbock W, Moessner A, Schnurrbusch UE, Holz FG, Wolf S; FAM Study Group. Changes in fundus autofluorescence in patients with age-related maculopathy. Correlation to visual function: a prospective study. Graefes Arch Clin Exp Ophthalmol. 2005 Apr;243(4):3 — View Citation

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. doi: 10.1001/archopht.126.10.1461. — View Citation

Holz FG, Bellman C, Staudt S, Schütt F, Völcker HE. Fundus autofluorescence and development of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2001 Apr;42(5):1051-6. — View Citation

Holz FG, Bellmann C, Margaritidis M, Schütt F, Otto TP, Völcker 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. — View Citation

Schmitz-Valckenberg S, Bindewald-Wittich A, Dolar-Szczasny J, Dreyhaupt J, Wolf S, Scholl HP, Holz FG; Fundus Autofluorescence in Age-Related Macular Degeneration Study Group. Correlation between the area of increased autofluorescence surrounding geograph — View Citation

Schmitz-Valckenberg S, Bültmann S, Dreyhaupt J, Bindewald A, Holz FG, Rohrschneider K. Fundus autofluorescence and fundus perimetry in the junctional zone of geographic atrophy in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. — View Citation

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. doi: 10.1016/j.ajo.2008.04.006. Epub 2008 Jun 2. — View Citation

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. doi: 10.1016/j.survophthal.2008.10.004. Review. — View Citation

Schmitz-Valckenberg S, Jorzik J, Unnebrink K, Holz FG; FAM Study Group. Analysis of digital scanning laser ophthalmoscopy fundus autofluorescence images of geographic atrophy in advanced age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of geographic atrophy size to baseline		36 months

External Links

•   German Research Council