Improving Function in Age-Related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

— IF-AMD  

Official title:

Improving Function in Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572039
• Other study ID #: 5U01EY015839
• Secondary ID: NEI grant
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2007
• Last updated: September 14, 2015
• Start date: August 2005
• Est. completion date: June 2013

Study information

• Verified date: September 2015
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Behavioral:
• PST
PST will be delivered in subjects' homes over the course of 6 weeks.
• ST
ST will be delivered in subjects' homes over the course of 6 weeks.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Jefferson University	Dartmouth-Hitchcock Medical Center, Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Targeted Vision Function (TVF)	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	No
Primary	Targeted Vision Function	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	No
Secondary	Vision-related Quality of Life	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	No
Secondary	Vision-related Quality of Life	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	No