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

Stopped early

Conditions studied: Geographic Atrophy

In brief

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.

Key facts

Study ID

NCT02479386

Run by

Hoffmann-La Roche

People needed

296

Starts

2015-06-24

Expected to finish

2018-01-31

Last updated by the study team

2019-08-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Retinal Diagnostic Center — Campbell, California, United States
• Specialty Eye Care Medical Center — Glendale, California, United States
• Jules Stein Eye Institute/ UCLA — Los Angeles, California, United States
• East Bay Retina Consultants — Oakland, California, United States
• Colorado Retina Associates, PC — Golden, Colorado, United States
• Rand Eye — Deerfield Beach, Florida, United States
• Bascom Palmer Eye Institute — Naples, Florida, United States
• Center For Sight — Sarasota, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Foundation for Vision Research — Grand Rapids, Michigan, United States
• MaculaCare, PLLC — New York, New York, United States
• Vitreous-Retina-Macula — New York, New York, United States
• University of North Carolina; Kittner Eye Center — Chapel Hill, North Carolina, United States
• Char Eye Ear &Throat Assoc — Charlotte, North Carolina, United States
• Duke University Eye Center; Vitreoretinal — Durham, North Carolina, United States
• Scheie Eye Institute — Philadelphia, Pennsylvania, United States
• Palmetto Retina Center — Florence, South Carolina, United States
• Retina Consultants of Houston — Houston, Texas, United States
• Med Center Ophthalmology Assoc — San Antonio, Texas, United States
• Wagner Macula & Retina Center — Norfolk, Virginia, United States
• Organizacion Medica de Investigacion — Buenos Aires, Argentina
• Oftalmos — Capital Federal, Argentina
• Northwest Arkansas Retina Associates — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

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