Home
Clinical Trials
Fundus Autofluorescence Imagi...

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

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-08-31

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Objective Assessment of Macular Function at Retinal and Cortical Levels

NCT03517241

Macula; Degeneration, Congenital or Hereditary Retina Disorder

UNKNOWN

Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

NCT06381596

Geographic Atrophy Age-Related Macular Degeneration

COMPLETED NA

Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases

NCT01546181

Retinal Dystrophies Age-related Macular Degeneration Arterial Hypertension +3 more

COMPLETED

Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration

NCT06694272

Age Related Macular Degeneration

RECRUITING

Performance of Long-wavelength Autofluorescence Imaging

NCT03592017

Retinal Disease Retinal Degeneration Retinal Dystrophies

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age-related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Frank G. Holz

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frank G Holz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, University of Aachen

Aachen, , Germany

Site Status

Department of Ophthalmology, University of Heidelberg

Heidelberg, , Germany

Site Status

Institute for Medical Statistics and Biometry, University of Heidelberg

Heidelberg, , Germany

Site Status

Department of Ophthalmology, University of Leipzig

Leipzig, , Germany

Site Status

• Institute for Biometry and Epidemiology, Ludwig-Maximilians-University

Munich, , Germany

Site Status

St. Franziskus Hospital Münster

Münster, , Germany

Site Status

Department of Ophthalmology, University of Würzburg

Würzburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1007/s004170050209.

Reference Type BACKGROUND

PMID: 9987631 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11274085 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19171212 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND

PMID: 18852430 (View on PubMed)

Schmitz-Valckenberg S, Fleckenstein M, Gobel 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.

Reference Type BACKGROUND

PMID: 18514607 (View on PubMed)

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 geographic atrophy and disease progression in patients with AMD. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2648-54. doi: 10.1167/iovs.05-0892.

Reference Type RESULT

PMID: 16723482 (View on PubMed)

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 atrophy in patients with age related macular degeneration. Br J Ophthalmol. 2005 Jul;89(7):874-8. doi: 10.1136/bjo.2004.057794.

Reference Type RESULT

PMID: 15965170 (View on PubMed)

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 (cSLO). BMC Ophthalmol. 2005 Apr 6;5:8. doi: 10.1186/1471-2415-5-8.

Reference Type RESULT

PMID: 15813972 (View on PubMed)

Schmitz-Valckenberg S, Bultmann 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. 2004 Dec;45(12):4470-6. doi: 10.1167/iovs.03-1311.

Reference Type RESULT

PMID: 15557456 (View on PubMed)

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. 2002 Feb;240(2):73-8. doi: 10.1007/s00417-001-0413-3.

Reference Type RESULT

PMID: 11933894 (View on PubMed)

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. doi: 10.1080/09286580591005723.

Reference Type RESULT

PMID: 16283987 (View on PubMed)

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 macular disease. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3309-14. doi: 10.1167/iovs.04-0430.

Reference Type RESULT

PMID: 16123434 (View on PubMed)

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):300-5. doi: 10.1007/s00417-004-1027-3. Epub 2004 Oct 13.

Reference Type RESULT

PMID: 15864618 (View on PubMed)

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. doi: 10.1001/archopht.120.5.579.

Reference Type RESULT

PMID: 12003606 (View on PubMed)

Pfau M, Lindner M, Goerdt L, Thiele S, Nadal J, Schmid M, Schmitz-Valckenberg S, Sadda SR, Holz FG, Fleckenstein M; Fundus Autofluorescence in Age-Related Macular Degeneration Study Group. PROGNOSTIC VALUE OF SHAPE-DESCRIPTIVE FACTORS FOR THE PROGRESSION OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2019 Aug;39(8):1527-1540. doi: 10.1097/IAE.0000000000002206.

Reference Type DERIVED

PMID: 29781974 (View on PubMed)

Lindner M, Kosanetzky S, Pfau M, Nadal J, Gordt LA, Schmitz-Valckenberg S, Schmid M, Holz FG, Fleckenstein M; FAM-Study Group. Local Progression Kinetics of Geographic Atrophy in Age-Related Macular Degeneration Are Associated With Atrophy Border Morphology. Invest Ophthalmol Vis Sci. 2018 Mar 20;59(4):AMD12-AMD18. doi: 10.1167/iovs.17-23203.

Reference Type DERIVED

PMID: 29558533 (View on PubMed)

Lindner M, Nadal J, Mauschitz MM, Luning A, Czauderna J, Pfau M, Schmitz-Valckenberg S, Holz FG, Schmid M, Fleckenstein M. Combined Fundus Autofluorescence and Near Infrared Reflectance as Prognostic Biomarkers for Visual Acuity in Foveal-Sparing Geographic Atrophy. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO61-BIO67. doi: 10.1167/iovs.16-21210.

Reference Type DERIVED

PMID: 28475704 (View on PubMed)

Lindner M, Boker A, Mauschitz MM, Gobel AP, Fimmers R, Brinkmann CK, Schmitz-Valckenberg S, Schmid M, Holz FG, Fleckenstein M; Fundus Autofluorescence in Age-Related Macular Degeneration Study Group. Directional Kinetics of Geographic Atrophy Progression in Age-Related Macular Degeneration with Foveal Sparing. Ophthalmology. 2015 Jul;122(7):1356-65. doi: 10.1016/j.ophtha.2015.03.027. Epub 2015 May 9.

Reference Type DERIVED

PMID: 25972258 (View on PubMed)

Fleckenstein M, Schmitz-Valckenberg S, Lindner M, Bezatis A, Becker E, Fimmers R, Holz FG; Fundus Autofluorescence in Age-Related Macular Degeneration Study Group. The "diffuse-trickling" fundus autofluorescence phenotype in geographic atrophy. Invest Ophthalmol Vis Sci. 2014 May 2;55(5):2911-20. doi: 10.1167/iovs.13-13409.

Reference Type DERIVED

PMID: 24699379 (View on PubMed)

Smailhodzic D, Fleckenstein M, Theelen T, Boon CJ, van Huet RA, van de Ven JP, Den Hollander AI, Schmitz-Valckenberg S, Hoyng CB, Weber BH, Holz FG, Klevering BJ. Central areolar choroidal dystrophy (CACD) and age-related macular degeneration (AMD): differentiating characteristics in multimodal imaging. Invest Ophthalmol Vis Sci. 2011 Nov 21;52(12):8908-18. doi: 10.1167/iovs.11-7926.

Reference Type DERIVED

PMID: 22003107 (View on PubMed)

Fleckenstein M, Schmitz-Valckenberg S, Adrion C, Visvalingam S, Gobel AP, Mossner A, von Strachwitz CN, Mackensen F, Pauleikhoff D, Wolf S, Mansmann U, Holz FG; FAM Study Group. Progression of age-related geographic atrophy: role of the fellow eye. Invest Ophthalmol Vis Sci. 2011 Aug 22;52(9):6552-7. doi: 10.1167/iovs.11-7298.

Reference Type DERIVED

PMID: 21757586 (View on PubMed)

Fleckenstein M, Schmitz-Valckenberg S, Martens C, Kosanetzky S, Brinkmann CK, Hageman GS, Holz FG. Fundus autofluorescence and spectral-domain optical coherence tomography characteristics in a rapidly progressing form of geographic atrophy. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3761-6. doi: 10.1167/iovs.10-7021.

Reference Type DERIVED

PMID: 21310912 (View on PubMed)

Schmitz-Valckenberg S, Fleckenstein M, Gobel AP, Hohman TC, Holz FG. Optical coherence tomography and autofluorescence findings in areas with geographic atrophy due to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):1-6. doi: 10.1167/iovs.10-5619.

Reference Type DERIVED

PMID: 20688734 (View on PubMed)

Fleckenstein M, Schmitz-Valckenberg S, Adrion C, Kramer I, Eter N, Helb HM, Brinkmann CK, Charbel Issa P, Mansmann U, Holz FG. Tracking progression with spectral-domain optical coherence tomography in geographic atrophy caused by age-related macular degeneration. Invest Ophthalmol Vis Sci. 2010 Aug;51(8):3846-52. doi: 10.1167/iovs.09-4533. Epub 2010 Mar 31.

Reference Type DERIVED

PMID: 20357194 (View on PubMed)

Fleckenstein M, Adrion C, Schmitz-Valckenberg S, Gobel AP, Bindewald-Wittich A, Scholl HP, Mansmann U, Holz FG; FAM Study Group. Concordance of disease progression in bilateral geographic atrophy due to AMD. Invest Ophthalmol Vis Sci. 2010 Feb;51(2):637-42. doi: 10.1167/iovs.09-3547. Epub 2009 Sep 24.

Reference Type DERIVED

PMID: 19797219 (View on PubMed)