Improving Function in Age-Related Macular Degeneration (IF-AMD)
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.
Age-Related Macular Degeneration
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Improving Function in Age-Related Macular Degeneration|
- Targeted Vision Function (TVF) [ Time Frame: 3-Months ] [ Designated as safety issue: No ]
- Vision-related Quality of Life [ Time Frame: 3-Months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Problem Solving Treatment (PST)
PST will be delivered in subjects' homes over the course of 6 weeks.
Placebo Comparator: ST
Supportive Therapy (ST)
ST will be delivered in subjects' homes over the course of 6 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572039
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Barry W Rovner, MD||Jefferson Medical College of Thomas Jefferson University|