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NCT00572039 · ClinicalTrials.gov registry record · Phase 3
Improving Function in Age-Related Macular Degeneration
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
NCT00572039 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 241 participants.
The verdict
NCT00572039, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
Study 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 dev
Interventions
- BEHAVIORAL PST
- BEHAVIORAL ST
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2005-08 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00572039
The ClinicalTrials.gov registry entry for NCT00572039 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PST is the first listed.
NCT00572039 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00572039 about?
NCT00572039 is a clinical study titled "Improving Function in Age-Related Macular Degeneration". 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. I...
What is the current status of trial NCT00572039?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2005-08. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00572039?
The interventions under investigation include: PST (BEHAVIORAL), ST (BEHAVIORAL).
Who is sponsoring clinical trial NCT00572039?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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