NCT00572039

Improving Function in Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized, controlled clinical trial will test the efficacy of Problem-Solving Treatment (PST) to improve vision function in older persons with age-related macular degeneration (AMD). AMD is a highly prevalent, disabling disease of aging that causes severe vision loss and functional decline. It is the leading cause of blindness in older persons in the United States and may affect more than 10 million people. Currently, there are no effective treatments to restore vision. Thus, improving Vision Function is a major goal of treatment. Vision function refers to vision-related abilities to perform daily living activities (e.g. reading recipes to prepare meals). Decrements in vision function will become a major public health problem as the population ages and the prevalence of AMD increases. PST is a brief, standardized, cognitive-behavioral treatment that teaches problem-solving skills. We believe PST will enable patients with AMD find practical solutions to vision-related problems and thereby improve vision function. We will recruit 240 AMD patients from the retina clinics of Wills Eye Institute, Philadelphia, PA, with bilateral AMD and visual acuity worse than 20/70 in the better eye. PST-trained therapists will deliver 6 1-hour, in-home sessions to the 120 subjects randomized to PST. The control treatment is Supportive Therapy (ST), a similarly structured, standardized psychological treatment that controls for the non-specific effects of treatment (n=120). ST contains no active elements beyond its non-specific components; in this way it is a placebo treatment. Independent raters, masked to treatment assignment, will assess Targeted Vision Function (primary outcome) and vision-related quality of life (secondary outcome) at 3 months to assess PST's efficacy, and at 6 months to evaluate its long-term effects. As the population ages, the disability of AMD will become more prevalent, costly, and burdensome to patients, families, and ophthalmologists. This makes devising and testing practical and affordable interventions to improve vision function a national priority.

Detailed description

The primary hypothesis will address treatment group differences in Targeted Vision Function at 3-months, and secondary hypotheses will the long-term effect (6-months) of Problem Solving Treatment (PST) on TVF and vision-related quality of life.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
BEHAVIORAL	PST	PST will be delivered in subjects' homes over the course of 6 weeks.
BEHAVIORAL	ST	ST will be delivered in subjects' homes over the course of 6 weeks.

Timeline

• Start date: 2005-08-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2007-12-12
• Last updated: 2025-04-15
• Results posted: 2015-10-15

Locations

1 site across 1 country: United States