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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

NCT02399072

TerminatedN/A

Sponsor: Hoffmann-La Roche

Conditions: Geographic Atrophy

Interventions: No intervention

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

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 also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 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 60 months.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Well-demarcated area of GA secondary to AMD
* Women of childbearing potential and men must agree to use adequate contraception for at least 30 days after fluorescein dye administration
* The study is recruiting participants in two different cohorts:

Cohort 1: Participants with unilateral GA OR Cohort 2: Participants with GA in one eye and CNV (active or treated) with or without GA, in the contralateral eye

Exclusion Criteria:

* Previous participation in any studies of investigational drugs for GA / dry AMD (exception 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/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
Locations (63)
  • Pensacola, Florida, United States
  • Chesterfield, Missouri, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Florence, South Carolina, United States
  • Nashville, Tennessee, United States
  • Abilene, Texas, United States
  • Dallas, Texas, United States
  • The Woodlands, Texas, United States
  • Willow Park, Texas, United States
  • Morgantown, West Virginia, United States
  • Buenos Aires, Argentina
  • Capital Federal, Argentina
  • Córdoba, Argentina
  • Córdoba, Argentina
  • Mendoza, Argentina
  • Parramatta, New South Wales, Australia
  • Adelaide, South Australia, Australia
  • East Melbourne, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Vancouver, British Columbia, Canada
  • Halifax, Nova Scotia, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Boisbriand, Quebec, Canada
  • Montreal, Quebec, Canada
  • Créteil, France
  • Dijon, France
  • + 33 more on CT.gov