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CompletedNCT02332343SIGHTUpdated May 8, 2017

Sparing of the Fovea in Geographic Atrophy Progression

An observational study in Atrophy, Geographic Atrophy and Age-related Macular Degeneration, sponsored by University Hospital, Bonn. Completed at 1 site in Germany. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2017-05-08.

Sponsored by University Hospital, Bonn · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
26
Ages
55 Years and older
Sex
All
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Study summary

Dry age-related macular degeneration (AMD) is a common cause for severe visual loss in the elderly and represents an unmet need. So far no treatment is available for geographic atrophy (GA), which represents the advanced dry form characterized by expanding areas of outer retinal atrophy with corresponding absolute scotoma. The foveal retina may be spared until late in the course of the disease, a phenomenon termed "foveal sparing". However, the disease process ultimately also involves the central retina leading to irreversible loss of central vision. While the natural history of eyes with GA has been extensively studied with regard to the entire atrophic area, morphology-function analyses for "foveal sparing" GA in particular are still missing. Such data are needed for various purposes including the future use in interventional pharmacological trials aiming to slow the progression of GA and to preserve the foveal retina. In this study, different imaging modalities for accurate detection and quantification of preserved foveal retinal areas will be assessed.

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Conditions studied

  • Atrophy
  • Geographic Atrophy
  • Age-related Macular Degeneration
  • Eye Diseases

Keywords

  • Retina
  • Retinal pigment epithelium
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 26 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suitable for the study will be recruited at the University of Bonn, Department of Ophthalmology

Inclusion criteria

  • Informed consent
  • The study eye must have a contiguous well-demarcated area of GA either in a complete ring around the spared fovea or in a horseshoe pattern with a total atrophy size of ≤ 7 Disk Areas
  • Patient is willing to undergo ocular examination

Exclusion criteria

Exclusion Criteria:

  • The presence or history of CNV (choroidal neovascular membrane) in the study eye
  • Ocular disease in the study eye that may confound assessment of the retina, other than non-exudative AMD (e.g., diabetic retinopathy, uveitis)
  • Cataract surgery or ocular surgery in the study eye within 30 days prior to the baseline visit
  • Current or previous participation in clinical studies investigating drugs, medical devices or supplements within 30 days prior to enrolment in the study - Previous or concomitant therapy to reat AMD (investigational or FDA approved); oral supplements of vitamins and minerals are permitted
  • Known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion
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Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention - Natural history study
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What researchers measure

Primary outcomes

  1. Best corrected visual acuity (BCVA)

    Time frame: baseline

Secondary outcomes

  1. Size of Geographic atrophy area as determined by confocal laser scanning ophthalmoscopy (in mm²)

    Time frame: baseline

  2. Size of foveal sparing area as determined by confocal laser scanning ophthalmoscopy (in mm²)

    Time frame: baseline

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Study locations

1 site
  • Department of Ophthalmology, University of Bonn
    Bonn, NRW 53127, Germany
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References and documents

Publications

  • Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. doi: 10.1016/j.ajo.2006.11.041. Epub 2006 Dec 22. PubMed 17239336 ↗
  • 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. Erratum In: Invest Ophthalmol Vis Sci. 2005 Jan;46(1):7. PubMed 15557456 ↗
  • Schmitz-Valckenberg S, Fleckenstein M, Helb HM, Charbel Issa P, Scholl HP, Holz FG. In vivo imaging of foveal sparing in geographic atrophy secondary to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3915-21. doi: 10.1167/iovs.08-2484. Epub 2009 Apr 1. PubMed 19339734 ↗
  • Lindner M, Pfau M, Czauderna J, Goerdt L, Schmitz-Valckenberg S, Holz FG, Fleckenstein M. Determinants of Reading Performance in Eyes with Foveal-Sparing Geographic Atrophy. Ophthalmol Retina. 2019 Mar;3(3):201-210. doi: 10.1016/j.oret.2018.11.005. Epub 2018 Nov 22. PubMed 31014695 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02332343
Lead sponsor
University Hospital, Bonn
Collaborators
Genentech, Inc.
Responsible party
Dr. Monika Fleckenstein (PD, Dr. med., University Hospital, Bonn) — Principal investigator
First posted
Jan 6, 2015
Start date
Oct 2014
Primary completion
Jan 2017
Completion
Jan 2017
Last update
May 8, 2017

Study contacts

Monika Fleckenstein, PD, Dr. med.
principal investigator · University of Bonn

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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