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

Roche

Status: Terminated

Conditions: Geographic Atrophy

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02399072

GX29639 (Other Identifier)

2014-003940-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

202 participants in 1 patient group

Geographic Atrophy Participants

Description:

Participants with unilateral GA or GA in one eye and choroidal neovascularization (CNV; active or treated) with or without GA, in the contralateral eye, will be evaluated for the progression of GA for up to approximately 60 months.

Treatment:

Other: No intervention