Geographic Atrophy
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
No intervention administered in this study
Sponsors
Hoffmann-La Roche
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60 | Baseline up to Month 60 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Functional Reading Independence Score up to Month 60 | Baseline up to Month 60 |
| Percentage of Participants With Medical Events | Baseline up to Month 60 |
| Percentage of Participants With Ocular Events | Baseline up to Month 60 |
| Change from Baseline in Near Activity Subscale as Assessed by National Eye Institute Visual Functioning Questionnaire 25-Item Version (NEI VFQ-25) up to Month 60 | Baseline up to Month 60 |
Countries
Argentina, Australia, Brazil, Canada, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States
Outcome results
None listed