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 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.
Interventions
OTHERNo intervention
No intervention was administered in this study.
Sponsors
Hoffmann-La Roche
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards | Baseline up to end of study (up to approximately 48 months) |
| Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards | Baseline up to end of study (up to approximately 48 months) |
| BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions | Baseline up to end of study (up to approximately 48 months) |
| Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP) | Baseline up to end of study (up to approximately 48 months) |
| Macular Sensitivity as Assessed by Mesopic MP | Baseline up to end of study (up to approximately 48 months) |
| Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart | Baseline up to end of study (up to approximately 48 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF) | Baseline, end of study (up to approximately 48 months) | — |
| Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score | Baseline, end of study (up to approximately 48 months) | — |
| Change from Baseline in Functional Reading Independence (FRI) Index Score | Baseline, end of study (up to approximately 48 months) | — |
| Percentage of Participants With Medical Events of Interest (MEIs) | Baseline up to end of study (up to approximately 48 months) | The clinical events (cardiovascular, respiratory, cognitive, ocular events etc.) occurring during the study are termed as MEIs. These events will be collected using MEI electronic Case Report Form (eCRF) checklist. |
Countries
Argentina, Australia, Austria, Brazil, Canada, France, Germany, Greece, Hungary, Israel, Italy, Poland, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed