Sparing of the Fovea in Geographic Atrophy Progression

Age-related Macular Degeneration Clinical Trial

— SIGHT  

Official title:

Sparing of the Fovea in Geographic Atrophy Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332343
• Other study ID #: 173/14
• Status: Completed
• Phase: N/A
• First received: January 4, 2015
• Last updated: May 5, 2017
• Start date: October 2014
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Atrophy
• Eye Diseases
• Geographic Atrophy
• Macular Degeneration

Intervention

Other:
• No intervention - Natural history study

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University of Bonn	Bonn	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Genentech, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group.. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. Epub 2006 Dec 22. — View Citation

Schmitz-Valckenberg S, Bültmann S, Dreyhaupt J, Bindewald A, Holz FG, Rohrschneider K. Fundus autofluorescence and fundus perimetry in the junctional zone of geographic atrophy in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4470-6. Erratum in: Invest Ophthalmol Vis Sci. 2005 Jan;46(1):7. — View Citation

Schmitz-Valckenberg S, Fleckenstein M, Helb HM, Charbel Issa P, Scholl HP, Holz FG. In vivo imaging of foveal sparing in geographic atrophy secondary to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3915-21. doi: 10.1167/iovs.08-2484. Epub 2009 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity (BCVA)		baseline
Secondary	Size of Geographic atrophy area as determined by confocal laser scanning ophthalmoscopy (in mm²)		baseline
Secondary	Size of foveal sparing area as determined by confocal laser scanning ophthalmoscopy (in mm²)		baseline