A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration



Status:Terminated
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:8/23/2018
Start Date:June 24, 2015
End Date:January 31, 2018

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A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

This study seeks to better characterize relationships between visual function and the
progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration
(AMD). The study is also intended to generate new information on the relationship between
genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study
enrolling participants with GA secondary to AMD. The study visits are scheduled to occur
every 6 months. The anticipated duration of the study is up to 48 months. There is a planned
interim analysis around the 2-year time window for the study.


Inclusion Criteria:

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of less than (<) 1 percent (%) per year for at least 30 days after the last
fluorescein dye administration

- The study is being conducted in participants with GA in both Study Eye and Non-Study
Eye (bilateral GA) with no evidence of prior or active choroidal neovascularization
(CNV)

Exclusion Criteria:

- Previous participation in any studies of investigational drugs for GA or dry AMD
(except for studies of vitamins and minerals)

- GA in either eye due to causes other than AMD

- History of vitrectomy surgery, submacular surgery, or any surgical intervention for
AMD

- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
occlusion, and/or proliferative diabetic retinopathy

- Any ocular or systemic medical conditions that, in the opinion of the investigator,
could contribute to participant's inability to participate in the study or interfere
with study assessments

- Requirement for continuous use of therapy indicated in Prohibited Therapy in the study
Protocol
We found this trial at
24
sites
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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725 Uruguay
Buenos Aires, C1015ABO
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Campbell, California 95008
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Chapel Hill, North Carolina 27517
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6035 Fairview Road
Charlotte, North Carolina 28210
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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5 West Sample Road
Deerfield Beach, Florida 33064
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2351 Erwin Road
Durham, North Carolina 27710
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Florence, South Carolina 29501
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Glendale, California 91203
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Golden, Colorado 80401
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Grand Rapids, Michigan 49546
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Houston, Texas 77030
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Los Angeles, California
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3880 Tamiami Trail North
Naples, Florida 34103
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New York, New York 10021
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460 Park Avenue
New York, New York 10022
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1800 Republic Road
Norfolk, Virginia 23451
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Oakland, California 94609
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Paducah, Kentucky 42001
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Philadelphia, Pennsylvania 19104
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9157 Huebner Road
San Antonio, Texas 78240
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Sarasota, Florida 34239
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601 Maple Drive
Springdale, Arkansas 72764
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