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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02332343
Other study ID # 173/14
Secondary ID
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
Health authority
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

Study Design


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
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