A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

Hoffmann-La Roche63 sites in 10 countries202 target enrollmentMarch 30, 2015

ConditionsGeographic Atrophy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Geographic Atrophy
Sponsor: Hoffmann-La Roche
Enrollment: 202
Locations: 63
Primary Endpoint: Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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 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.

Registry

clinicaltrials.gov

Start Date

March 30, 2015

End Date

February 8, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60

Time Frame: Baseline up to Month 60

Secondary Outcomes

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)
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 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 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 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 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)
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)