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

NCT02479386

TerminatedN/A

Sponsor: Hoffmann-La Roche

Conditions: Geographic Atrophy

Interventions: No intervention

Countries: United States, Argentina, Australia, Austria, Brazil, Canada, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (91)
  • Springdale, Arkansas, United States
  • Campbell, California, United States
  • Glendale, California, United States
  • Los Angeles, California, United States
  • Oakland, California, United States
  • Golden, Colorado, United States
  • Deerfield Beach, Florida, United States
  • Naples, Florida, United States
  • Sarasota, Florida, United States
  • Chicago, Illinois, United States
  • Paducah, Kentucky, United States
  • Baltimore, Maryland, United States
  • Grand Rapids, Michigan, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Florence, South Carolina, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Norfolk, Virginia, United States
  • Buenos Aires, Argentina
  • Capital Federal, Argentina
  • Córdoba, Argentina
  • Córdoba, Argentina
  • Mar del Plata, Argentina
  • Rosario, Argentina
  • Mona Vale, New South Wales, Australia
  • + 61 more on CT.gov