OBJECTIVES: Age-related macular degeneration (AMD) is the leading cause of blindness in the developed countries and accounted for 8.7 million cases of blindness around the world in 2002. Insufficient documentation of the impact of AMD on patients and their caregivers limits our understanding of the disease burden. The objective of this study is to document the humanistic and economic impact of exudative (wet) AMD on elderly subjects and compare it to a population group not affected by the disease. METHODS: This is a multinational, cross-sectional, observational study of self-reported functional health and disease burden among elderly subjects with and without subfoveal, exudative AMD. Each of the five participating countries, Canada, France, Germany, Spain, and the UK, will recruit 100 bilateral AMD patients and 100 controls. The primary objective is to compare the difference in humanistic impact as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ25) between AMD patients and control group of similar age patients in general medical care. Other end points include assessment of the disparity in health-related quality of life burden due to wet AMD compared to non-AMD controls using the EuroQol and Hospital Anxiety and Depression Scale. Information on resource utilization and economic impact of AMD on patients and caregivers will be collected form physicians and patients. RESULTS: Data collection began in April 2005 and is expected to complete by November 2005. Final analysis will use standard bivariate and multivariate methods to explore relationships between severity of AMD and sociodemographic characteristics, health-related quality of life, depression, falls, and resource utilization variables. Summary analysis will be conducted in aggregate and by country. CONCLUSIONS: Analysis of a wide range of factors affecting AMD patients will provide useful guidance to healthcare providers, payers, and AMD support groups when determining the benefits of emerging therapies for wet AMD.