Improving Function in Age-Related Macular Degeneration

NCT00572039 | Completed Phase 3 Results DMC

• 2 other identifiers: 5U01EY015839NEI grant
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Keywords

Age-Related Macular Degeneration; AMD; Vision Function; Problem Solving Treatment; PST

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Vision-related Quality of Life

  3-Months

• Vision-related Quality of Life

  6 months

Study Arms (2)

PST

EXPERIMENTAL

Problem Solving Treatment (PST)

Behavioral: PST

ST

PLACEBO COMPARATOR

Supportive Therapy (ST)

Behavioral: ST

Interventions

PST BEHAVIORAL

PST will be delivered in subjects' homes over the course of 6 weeks.

PST

ST BEHAVIORAL

ST will be delivered in subjects' homes over the course of 6 weeks.

ST

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Dartmouth College: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 21746979 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Barry W. Rovner, MD
• Organization: Thomas Jefferson University

Barry.Rovner@jefferson.edu

2155031254

Study Officials

• Barry W Rovner, MD

  Jefferson Medical College of Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: August 1, 2005
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 15, 2025
• Results First Posted: October 15, 2015

Record last verified: 2025-04

Locations

US (1)