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Directional Spread in Geographic Atrophy (DSGA)

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ClinicalTrials.gov Identifier: NCT02051998
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Monika Fleckenstein, MD, University Hospital, Bonn

Brief Summary:
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. The DSGA study is the extension trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study (NCT00393692).

Condition or disease
Nonexudative Age-related Macular Degeneration

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD)
Study Start Date : June 2013
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change of geographic atrophy size to baseline [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Change in BCVA from baseline [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051998


Locations
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Germany
Department of Ophthalmology, University of Bonn
Bonn, NRW, Germany, 53127
Sponsors and Collaborators
University Hospital, Bonn
Investigators
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Principal Investigator: Monika Fleckenstein, Prof. Dr. med. Department of Ophthalmology, University of Bonn
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. Monika Fleckenstein, MD, Prof. Dr. med., University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT02051998    
Other Study ID Numbers: FL 658/4-1 and FL 658/4-2
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by Prof. Dr. Monika Fleckenstein, MD, University Hospital, Bonn:
Geographic atrophy
Age-related macular degeneration
Retina
Retinal pigment epithelium
Optical coherence tomography
Scanning laser ophthalmoscopy
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical