Sparing of the Fovea in Geographic Atrophy Progression

Completed

• Conditions: Atrophy; Geographic Atrophy; Age-related Macular Degeneration; Eye Diseases

• Registration Number: NCT02332343
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-04
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA)	baseline

Secondary Outcome Measures

Name	Time	Method
Size of Geographic atrophy area as determined by confocal laser scanning ophthalmoscopy (in mm²)	baseline
Size of foveal sparing area as determined by confocal laser scanning ophthalmoscopy (in mm²)	baseline

Trial Locations

Locations (1)

Department of Ophthalmology, University of Bonn; 🇩🇪 Bonn, NRW, Germany