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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PST
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Targeted Vision Function (TVF)
Time Frame: 3-Months
|
We identified and quantified the TVF goals that subjects valued but found difficult to achieve.
To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them.
If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its "difficulty" (on a scale of 0 [not difficult] to 4 [impossible]).
The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4).
Higher average scores indicate greater disability.
At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.
|
3-Months
|
|
Targeted Vision Function
Time Frame: 6 months
|
We identified and quantified the TVF goals that subjects valued but found difficult to achieve.
To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them.
If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its "difficulty" (on a scale of 0 [not difficult] to 4 [impossible]).
The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4).
Higher average scores indicate greater disability.
At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vision-related Quality of Life
Time Frame: 3-Months
|
We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19
This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL.
The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss.
Scores range from 0 to 100, with higher scores indicating better function.
|
3-Months
|
|
Vision-related Quality of Life
Time Frame: 6 months
|
We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19
This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL.
The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss.
Scores range from 0 to 100, with higher scores indicating better function.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barry W Rovner, MD, Jefferson Medical College of Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5U01EY015839 (U.S. NIH Grant/Contract)
- NEI grant
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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