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OpenTrials
Completed

NCT Number: NCT02332343

Sparing of the Fovea in Geographic Atrophy Progression

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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Key information

Conditions

Atrophy Age-Related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University of Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention - Natural history study

Other

Primary outcomes

  1. Best corrected visual acuity (BCVA)

    Time frame: baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Collaborators

  • Genentech, Inc.

Registry information

Acronym: SIGHT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2015
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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