A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Geographic Atrophy
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 296
- Locations
- 91
- Primary Endpoint
- Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards
Time Frame: Baseline up to end of study (up to approximately 48 months)
BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions
Time Frame: Baseline up to end of study (up to approximately 48 months)
Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)
Time Frame: Baseline up to end of study (up to approximately 48 months)
Macular Sensitivity as Assessed by Mesopic MP
Time Frame: 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
Time Frame: Baseline up to end of study (up to approximately 48 months)
Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards
Time Frame: Baseline up to end of study (up to approximately 48 months)
Secondary Outcomes
- Change from Baseline in Functional Reading Independence (FRI) Index Score(Baseline, end of study (up to approximately 48 months))
- 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))
- Percentage of Participants With Medical Events of Interest (MEIs)(Baseline up to end of study (up to approximately 48 months))