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Age-related Macular DegenerationNCT00393692

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

An observational study of Age-related Macular Degeneration, run by University Hospital, Bonn at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Age-related Macular Degeneration
How many people
700 participants
Where
7 sitesGermany
Study dates
Aug 2000to Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with unilateral or bilateral geographic atrophy due to AMD, aged 50 years and older. German population

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Department of Ophthalmology, University of Aachen

    Aachen, 52074

  • Department of Ophthalmology, University of Heidelberg

    Heidelberg, 69120

  • Institute for Medical Statistics and Biometry, University of Heidelberg

    Heidelberg, 69120

  • Department of Ophthalmology, University of Leipzig

    Leipzig, 04103

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

    Munich, 81377

  • St. Franziskus Hospital Münster

    Münster, 48145

  • Department of Ophthalmology, University of Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

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

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.

Read the 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.

Keywords
Age-related macular degeneration, Geographic atrophy, drusen
Medical subject headings
Macular Degeneration, Geographic Atrophy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of geographic atrophy size to baseline

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2006 (estimated)
  2. Study startAug 2000
  3. Primary completionApr 2016
  4. Study completionOct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00393692
Sponsor's protocol ID
FAM-Study
Other IDs
DFG Priority Program AMD, SPP 1088, Ho 1926/1-3, Ho 1926/3-1, Ma 1723/1-1
Status last verified
Oct 2018
First submitted
26 Oct 2006
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 9987631

  • 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.

    PubMed 11274085

  • 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.

    PubMed 19171212

  • 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.

    PubMed 18852430

  • 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.

    PubMed 18514607

  • 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.

    PubMed 16723482

  • 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.

    PubMed 15965170

  • 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.

    PubMed 15813972

  • 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.

    PubMed 15557456

  • 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.

    PubMed 11933894

  • 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.

    PubMed 16283987

  • 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.

    PubMed 16123434

  • 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.

    PubMed 15864618

  • 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.

    PubMed 12003606

  • 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.

    PubMed 29781974

Questions about this trial

What is this clinical trial studying?

An observational study of Age-related Macular Degeneration, run by University Hospital, Bonn at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of geographic atrophy size to baseline (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00393692, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.

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