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Sparing of the Fovea in Geographic Atrophy Progression (SIGHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02332343
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dr. Monika Fleckenstein, University Hospital, Bonn

Brief 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.

Condition or disease Intervention/treatment
Atrophy Geographic Atrophy Age-related Macular Degeneration Eye Diseases Other: No intervention - Natural history study

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Sparing of the Fovea in Geographic Atrophy Progression
Study Start Date : October 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Best corrected visual acuity (BCVA) [ Time Frame: baseline ]

Secondary Outcome Measures :
  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 ]


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
  • 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:

  • 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

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): NCT02332343


Locations
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Germany
Department of Ophthalmology, University of Bonn
Bonn, NRW, Germany, 53127
Sponsors and Collaborators
University Hospital, Bonn
Genentech, Inc.
Investigators
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Principal Investigator: Monika Fleckenstein, PD, Dr. med. University of Bonn

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Monika Fleckenstein, PD, Dr. med., University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT02332343    
Other Study ID Numbers: 173/14
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Keywords provided by Dr. Monika Fleckenstein, University Hospital, Bonn:
Retina
Retinal pigment epithelium
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Eye Diseases
Retinal Degeneration
Retinal Diseases
Pathological Conditions, Anatomical