Sparing of the Fovea in Geographic Atrophy Progression (SIGHT)
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ClinicalTrials.gov Identifier: NCT02332343
Recruitment Status :
First Posted : January 6, 2015
Last Update Posted : May 8, 2017
University Hospital, Bonn
Information provided by (Responsible Party):
Dr. Monika Fleckenstein, University Hospital, Bonn
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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Layout table for eligibility information
Ages Eligible for Study:
55 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients suitable for the study will be recruited at the University of Bonn, Department of Ophthalmology
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
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