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

Overview

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.

Full Title of Study: “A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration”

Study Type

  • Study Type: Observational
  • Study Primary Completion Date: April 14, 2017

Interventions

  • Other: No intervention
    • No intervention was administered in this study.

Arms, Groups and Cohorts

  • Cohort Geographic Atrophy
    • Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions
    • 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)
  • 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)

Secondary Measures

  • Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)
    • Time Frame: 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
    • Time Frame: Baseline, end of study (up to approximately 48 months)
  • Change from Baseline in Functional Reading Independence (FRI) Index Score
    • Time Frame: Baseline, end of study (up to approximately 48 months)
  • Percentage of Participants With Medical Events of Interest (MEIs)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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