Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00005900

Trial Description

start of 1:1-Block title

Title

Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

DSGA

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in
industrial countries. In the late stages of the disease, neovascular changes or the
development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by
the development of areas of outer retinal atrophy with continuous spread over time that is
corresponded to an visual field defect for the patient. The pathogenesis is still
incompletely understood. Despite the break-through in the treatment of neovascular AMD by
intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is
yet no treatment available to slow down or halt the disease process in GA. We and others
have demonstrated that the total GA area progression shows large differences between
patients. Potential factors influencing differential progression have been intensely
studied: While neither systemic nor genetic factors have been shown to influence GA
progression, ocular characteristics such as GA baseline size or phenotypic features of
fundus autofluorescence (FAF) abnormalities have been identified as risk characteristics for
increased GA progression. While these previous studies have mainly focused on the
characterization of total GA area progression, topographic directional spread has not been
analyzed and relevant predictive markers are yet unknown. There may be large differences in
the local GA progression. The primary objective of this study is to identify specific
characteristics, for the local GA progression. The knowledge of such risk factors may help
to better understand the pathogenesis of GA. The identification of predictive markers will
allow for better prognostic assessment of the individual disease process.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005900
  •   2015/03/03
  •   2014/01/08
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02051998  (ClinicalTrials.gov)
  •   FL 658/4-1  (University Hospital, Bonn)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Nonexudative Age-related Macular Degeneration
  •   H35.3 -  Degeneration of macula and posterior pole
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Change of geographic atrophy size to baseline; time frame: 24 months

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Change in BCVA from baseline; time frame: 24 months

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2013/06/30
  •   130
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Informed consent

- Men and women, any race, aged 55 years or older at the baseline visit

- If both eyes meet the criteria to be study eye either eye will be included into the
analysis.

- Patient is willing to undergo ocular examinations once every 6 for up to 24 months

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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)

- Any systemic disease with a limited survival prognosis (e.g., cancer, severe/unstable
cardiovascular disease).

- Any condition that would make adherence to the examination schedule of once every 6
months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic
alcoholism, Alzheimer's Disease or drug abuse

- Known medical history of allergy or sensitivity to tropicamide or fluorescein dye
that is clinically relevant in the investigator's opinion

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University Hospital, Bonn
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Department of Ophthalmology, University of Bonn
    • Monika Fleckenstein, PD, Dr. med. 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Moritz Lindner, Dr. med. 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Webpage of the University Eye Hospital of Bonn
  •   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. Epub 2006 Dec 22.; 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. Erratum in: Invest Ophthalmol Vis Sci. 2005 Jan;46(1):7.; 15557456
  •   Fleckenstein M, Adrion C, Schmitz-Valckenberg S, Göbel 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. Epub 2009 Sep 24.; 19797219
  •   Schmitz-Valckenberg S, Brinkmann CK, Alten F, Herrmann P, Stratmann NK, Göbel AP, Fleckenstein M, Diller M, Jaffe GJ, Holz FG. Semiautomated image processing method for identification and quantification of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7640-6. doi: 10.1167/iovs.11-7457.; 21873669
  •   Fleckenstein M, Charbel Issa P, Helb HM, Schmitz-Valckenberg S, Finger RP, Scholl HP, Loeffler KU, Holz FG. High-resolution spectral domain-OCT imaging in geographic atrophy associated with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):4137-44. doi: 10.1167/iovs.08-1967. Epub 2008 May 16.; 18487363
  •   Fleckenstein M, Schmitz-Valckenberg S, Adrion C, Krämer 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. Epub 2010 Mar 31.; 20357194
  •   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. Print 2011 May.; 21310912
  •   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.; 19339734
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.