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

Roche

Status: Terminated

Conditions: Geographic Atrophy

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02479386

2014-003939-19 (EudraCT Number)

GX29633

GX29639 (Other Identifier)

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 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.

Enrollment: 296 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

296 participants in 1 patient group

Cohort Geographic Atrophy

Description:

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

Treatment:

Other: No intervention