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Age-related Macular DegenerationPhase 3VITALNCT00769015

Low Vision Depression Prevention Trial for Age Related Macular Degeneration

A Phase 3 study testing BA-LVR and ST-LVR in people with Age-related Macular Degeneration and Depression, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Age-related Macular Degeneration, Depression
What is being tested?
BA-LVR and ST-LVR
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
1 siteUnited States
Study dates
Jun 2009to Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age at least 65 years old
  • Bilateral AMD
  • Subthreshold depressive symptoms
  • At least 1 vision goal that is important yet difficult to carry out

Who cannot join

  • Uncontrolled glaucoma, diabetic retinopathy, corneal dystrophy, or cataracts for which surgery within 6 months is likely will be exclusionary conditions
  • Current diagnosis of depression
  • Cognitive impairment
  • Life-threatening illness or any other health conditions that interferes with study activities.
  • Patients who have received low vision rehabilitation or home-based OT in the preceding 12 months will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.

Read the detailed description

Age-related macular degeneration (AMD) is the leading cause of blindness in older persons in the U.S. and affects more than 10 million people. One third of patients with AMD become clinically depressed when they lose the ability to pursue valued activities. Because their depression is disabling and unlikely to be treated, preventing depression in AMD is a public health imperative as the population ages.

We will recruit 200 subjects who have bilateral AMD and subthreshold depressive symptoms. Their bilateral vision loss and subthreshold depressive symptoms increase their risk to develop more severe depressive disorders and functional decline. We will randomize eligible subjects to collaborative Low Vision Rehabilitation (LVR) (optometrist and home-based OT) or enhanced LVR (optometrist and home-based Supportive Therapy). In this study, usual care LVR is enhanced with Supportive Therapy (ST), which is a standardized placebo psychological treatment that controls for attention.

Many older persons with AMD understandably become depressed when their vision loss prevents them from pursuing valued goals. This necessitates a disease management strategy that combines treatment for vision loss and depression. Because depression in AMD is rarely treated, preventing depression is more sensible than waiting to treat it after diagnosis or failing to treat it at all. As the population ages and more people are affected with AMD, finding ways to prevent depression and improve daily functioning has great public health importance. For these reasons, the VITAL Trial has high clinical significance to patients with AMD, and wider public health significance as our society confronts the challenge of caring for the growing population of older adults with chronic disabilities.

Being tested
BA-LVR, ST-LVR
Keywords
age-related macular degeneration, depression, vision loss
Medical subject headings
Macular Degeneration, Depression, Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BA-LVRBehavioural

    Low vision clinic-based optometry plus 6 in-home occupational therapy visits

  • ST-LVRBehavioural

    Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Study groups in NCT00769015
Study groupRoleWhat they receive
BA-LVRExperimentalIn BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
Receives: Behavioral: BA-LVR
ST-LVRPlacebo comparatorSubjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
Receives: Behavioral: ST-LVR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

    The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.

    Measured: 4 months

Secondary outcomes (6)

  1. Vision Function: Distance Activities

    Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.

    Measured: 4 months

  2. Quality of Life: Dependency

    Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.

    Measured: 4 months

  3. Vision Function: Near Activities

    Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.

    Measured: 4 months

  4. Quality of Life: Mental Health

    Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.

    Measured: 4 months

  5. Quality of Life: Role Functioning

    Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.

    Measured: 4 months

  6. Quality of Life: Social Function

    Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2008 (estimated)
  2. Study startJun 2009
  3. Primary completionJan 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00769015
Sponsor's protocol ID
1U01EY018819
Acronym
VITAL
Status last verified
Nov 2014
First submitted
7 Oct 2008
Last updated
20 Nov 2014
Data monitoring committee
Yes

Publications

  • Rovner BW, Casten RJ, Hegel MT, Massof RW, Leiby BE, Ho AC, Tasman WS. Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial. Ophthalmology. 2014 Nov;121(11):2204-11. doi: 10.1016/j.ophtha.2014.05.002. Epub 2014 Jul 9.

    PubMed 25016366

  • Deemer AD, Massof RW, Rovner BW, Casten RJ, Piersol CV. Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2017 Mar 1;58(3):1514-1520. doi: 10.1167/iovs.16-20001.

    PubMed 28273318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BA-LVR and ST-LVR in people with Age-related Macular Degeneration and Depression, run by Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00769015, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.

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