Clinical trial NCT00572039: Improving Function in Age-Related Macular Degeneration
Official title: Improving Function in Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age-Related Macular Degeneration
Keywords: Age-Related Macular Degeneration
AMD
Vision Function
Problem Solving Treatment
PST
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: Johns Hopkins University
First posted: 2007-12-12
Enrollment: 241
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Being at least 65 years old
* Having bilateral Age-Related Macular Degeneration (AMD) (atrophic or neovascular)
* Having a best corrected visual acuity of 20/70 or worse
* Moderate difficulty in at least one valued vision functional goal

Exclusion Criteria:

* Ophthalmologic Criteria. Patients who have uncontrolled glaucoma (continued visual field loss and increase in optic nerve cupping), diabetic retinopathy (due to macular edema), or cataracts for which surgery within 6 months is likely will not be eligible to participate. This information will be obtained from patients' ophthalmology charts and discussion with the patient's ophthalmologist.
* Cognitive Impairment Criteria. Cognitive functioning will be evaluated by the Project Director during the telephone screen (see Chapter 9). Patients with cognitive impairment will not be eligible to participate.
* Health Criteria. Patients with life-threatening illness (e.g., terminal cancer, need for oxygen) will not be eligible to participate. Information regarding heath status will be gleaned from patient's ophthalmology charts.

Primary outcomes:
measure: Targeted Vision Function (TVF)
timeFrame: 3-Months
measure: Targeted Vision Function
timeFrame: 6 months
Secondary outcomes:
measure: Vision-related Quality of Life
timeFrame: 3-Months
measure: Vision-related Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Jefferson Medical College of Thomas Jefferson University
name: Barry W Rovner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rovner BW, Casten RJ, Massof RW, Leiby BE, Tasman WS; Wills Eye AMD Study. Psychological and cognitive determinants of vision function in age-related macular degeneration. Arch Ophthalmol. 2011 Jul;129(7):885-90. doi: 10.1001/archophthalmol.2011.146.