Trial Outcomes & Findings for Improving Function in Age-Related Macular Degeneration (NCT NCT00572039)
NCT ID: NCT00572039
Last Updated: 2025-04-15
Results Overview
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.
COMPLETED
PHASE3
241 participants
3-Months
2025-04-15
Participant Flow
Participant milestones
| Measure |
Problem Solving Treatment
Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
|
Supportive Therapy
Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives.
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
120
|
|
Overall Study
COMPLETED
|
105
|
110
|
|
Overall Study
NOT COMPLETED
|
16
|
10
|
Reasons for withdrawal
| Measure |
Problem Solving Treatment
Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
|
Supportive Therapy
Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Ill
|
5
|
1
|
Baseline Characteristics
Improving Function in Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Problem Solving Treatment
n=121 Participants
Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks.
|
Supportive Therapy
n=120 Participants
Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82.7 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
82.8 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
82.7 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=5 Participants
|
120 participants
n=7 Participants
|
241 participants
n=5 Participants
|
|
Targeted vision function
|
2.71 units on a scale
STANDARD_DEVIATION .52 • n=5 Participants
|
2.73 units on a scale
STANDARD_DEVIATION .52 • n=7 Participants
|
2.72 units on a scale
STANDARD_DEVIATION .52 • n=5 Participants
|
|
NEI VFQ-25 + supplement total score
|
66.2 units on a scale
STANDARD_DEVIATION 14.3 • n=5 Participants
|
65.8 units on a scale
STANDARD_DEVIATION 14.2 • n=7 Participants
|
66.0 units on a scale
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Patient Health Questionnaire-9
|
1.39 units on a scale
STANDARD_DEVIATION 2.67 • n=5 Participants
|
1.17 units on a scale
STANDARD_DEVIATION 2.28 • n=7 Participants
|
1.28 units on a scale
STANDARD_DEVIATION 2.48 • n=5 Participants
|
|
Number of resources/rehabilitative devices used
|
5.14 number of resources/devices used
STANDARD_DEVIATION 3.34 • n=5 Participants
|
4.71 number of resources/devices used
STANDARD_DEVIATION 3.02 • n=7 Participants
|
4.93 number of resources/devices used
STANDARD_DEVIATION 3.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3-MonthsPopulation: 106 PST and 112 ST participants provided data at 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.
Outcome measures
| Measure |
Problem Solving Treatment
n=106 Participants
Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks.
|
Supportive Therapy
n=112 Participants
Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks.
|
|---|---|---|
|
Targeted Vision Function (TVF)
|
2.18 units on a scale
Standard Error .88
|
2.14 units on a scale
Standard Error .96
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 105 PST and 110 ST participants provided data at 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.
Outcome measures
| Measure |
Problem Solving Treatment
n=105 Participants
Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks.
|
Supportive Therapy
n=110 Participants
Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks.
|
|---|---|---|
|
Targeted Vision Function
|
2.18 units on a scale
Standard Deviation .95
|
2.15 units on a scale
Standard Deviation .96
|
SECONDARY outcome
Timeframe: 3-MonthsPopulation: 106 PST and 112 ST participants provided data at 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.
Outcome measures
| Measure |
Problem Solving Treatment
n=106 Participants
Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks.
|
Supportive Therapy
n=112 Participants
Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks.
|
|---|---|---|
|
Vision-related Quality of Life
|
66.6 units on a scale
Standard Deviation 14.9
|
65.2 units on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 105 PST and 110 ST participants provided data at 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.
Outcome measures
| Measure |
Problem Solving Treatment
n=105 Participants
Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks.
|
Supportive Therapy
n=110 Participants
Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks.
|
|---|---|---|
|
Vision-related Quality of Life
|
66.4 units on a scale
Standard Deviation 16.7
|
64.8 units on a scale
Standard Deviation 17.4
|
Adverse Events
Problem Solving Treatment
Supportive Therapy
Serious adverse events
| Measure |
Problem Solving Treatment
n=121 participants at risk
Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
|
Supportive Therapy
n=120 participants at risk
Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
4.1%
5/121 • Number of events 5
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fall
|
5.0%
6/121 • Number of events 6
|
6.7%
8/120 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Amputation
|
0.83%
1/121 • Number of events 1
|
0.00%
0/120
|
|
Cardiac disorders
Congestive Heart Failure
|
1.7%
2/121 • Number of events 2
|
2.5%
3/120 • Number of events 3
|
|
Cardiac disorders
Death due to CHF
|
0.83%
1/121 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Cardiac event
|
3.3%
4/121 • Number of events 4
|
1.7%
2/120 • Number of events 2
|
|
Vascular disorders
Stroke
|
2.5%
3/121 • Number of events 3
|
1.7%
2/120 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration/anemia
|
0.00%
0/121
|
2.5%
3/120 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Knee pain/back pain
|
0.83%
1/121 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.83%
1/121 • Number of events 1
|
4.2%
5/120 • Number of events 5
|
|
Endocrine disorders
hypoglycemia
|
0.83%
1/121 • Number of events 1
|
0.00%
0/120
|
|
Vascular disorders
Varicosities
|
0.83%
1/121 • Number of events 1
|
0.00%
0/120
|
|
General disorders
Death NOS
|
1.7%
2/121 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pagets diesease
|
0.00%
0/121
|
0.83%
1/120 • Number of events 1
|
|
Vascular disorders
Subdural hematoma
|
0.00%
0/121
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.83%
1/121 • Number of events 1
|
0.00%
0/120
|
|
Gastrointestinal disorders
Severe reflux, Hiatal hernia, Bowel obstruction
|
2.5%
3/121 • Number of events 3
|
0.00%
0/120
|
|
Nervous system disorders
Syncope
|
0.83%
1/121 • Number of events 1
|
0.00%
0/120
|
|
Musculoskeletal and connective tissue disorders
Myasthenia Gravis
|
0.83%
1/121 • Number of events 1
|
0.00%
0/120
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.83%
1/121 • Number of events 1
|
0.00%
0/120
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place