STATEMENT OF NEED
Age-related macular degeneration (AMD) is associated with aging, and gradually destroys sharp, central vision. Central vision is needed for seeing objects clearly and for common daily tasks such as reading and driving.
AMD affects the macula, the part of the eye that allows you to see fine detail. AMD causes no pain.
In some cases, AMD advances so slowly that people notice little change in their vision. In other people, the disease progresses faster and may lead to a loss of vision in both eyes. AMD is a leading cause of vision loss in Americans aged ≥60 years.
TARGET AUDIENCE
This activity is designed for retinal specialists and other ophthalmologists.
LEARNING OBJECTIVES
Upon successful completion of this learning program, the participant should be able to:
- Discuss the importance of quality-of-life studies in AMD.
- Cite information that shows how quality of life deteriorates among AMD patients.
- Explain the link between depression and AMD.
- Discuss the ways in which quality of life is measured in patients with AMD.
- Identify the ways in which quality of life may be improved in these patients.
METHOD OF INSTRUCTION
Participants should read the learning objectives and continuing medical education (CME) program in its entirety. After reviewing the material, they must complete the self-assessment test, which consists of a series of multiple-choice questions. This test is available exclusively online, at www.CMEToday.net. Once you register and log in, you can take the test, get real-time results, and print out your certificate. E-mail ckoury@bmctoday.com or call 484-581-1821 if you have any questions or technical problems with the Web site.
Upon completing the activity and achieving a passing score of ≥70% on the self-assessment test, participants can print out a CME credit letter awarding AMA/PRA Category 1 Credit.™ The estimated time to complete this activity is 1 hour.
ACCREDITATION
This activity has been planned and implemented in accordance with the Essentials and Standards of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of The Dulaney Foundation and Retina Today.
The Dulaney Foundation designates this educational activity for a maximum of 1 AMA/PRA Category 1 Credit.™ Physicians should only claim credit commensurate with the extent of their participation in the activity.
DISCLOSURE
In accordance with the disclosure policies of The Dulaney Foundation and to conform with ACCME and Food and Drug Administration (FDA) guidelines, all program faculty are required to disclose to the activity participants: (1) the existence of any financial interest or other relationships with the manufacturers of any commercial products/devices, or providers of commercial services that relate to the content of their presentation/material or the commercial contributors of this activity; and (2) identification of a commercial product/device that is unlabeled for use or an investigational use of a product/device not yet approved.
FACULTY CREDENTIALS
Tom S. Chang, MD, FRCS, MHSc, founded the Retina Institute of California in November 2005. Before that he was Associate Professor of Ophthalmology at the Doheny Eye Institute and Director of the Retina Fellowship. He may be reached at tomschang@retinainstituteca.com.
FACULTY DISCLOSURE DECLARATIONS
Dr. Chang disclosed that he is a consultant for iScience Interventional, Regeneron Pharmaceuticals, Novartis, ISTAPharm, CRT Health, and Genentech.
INTRODUCTION
One of the most significant effects of visual impairment in patients with age-related macular degeneration (AMD) is the associated degradation of their quality of life.
The field of quality-of-life (QOL) research is one in which patients' subjective experiences are translated into reproducible data that are robust enough to allow analysis with parametric statistics. The field is generally divided into two broad classes:
- Generic QOL research, which assays overall systemic health issues related to mental and physical well-being.
- Vision-related QOL (VR-QOL), in which parameters related to visual function specifically are examined.
Most retina clinicians can infer the VR-QOL deficits experienced by patients with AMD who are legally blind (visual acuity of 20/200 or worse). These individuals note increasing difficulties in carrying out daily activities and experience greater emotional distress, compared with similarly aged adults in their community. It has been determined that people with AMD who are legally blind rate their QOL and emotional distress similarly to individuals with chronic systemic diseases such as arthritis, chronic obstructive pulmonary disease and AIDS.1
Visual impairment is associated with a loss of independence and mobility. Patients with AMD lose the ability to perform tasks of daily living such as cooking, cleaning, and navigating their living spaces,1 not to mention the right to drive with the onset of legal blindness. Population-based studies have found that visual impairment is associated with increased risk of falls and hip fractures, a further threat to patients' independence.2-4
Equally important, AMD is also associated with clinical depression, (see sidebar, Depression Increases in Those With AMD, Treatments Show Promise). In one study, people with visual acuity of 20/60 or worse in their better eye due to AMD were approximately twice as likely as age-matched controls to meet the criteria for clinical depression.5
MEASURING VR-QOL
The studies cited merely confirm what ophthalmologists already know though daily interactions with AMD patients—that vision loss is a frightening, life-changing event that can have a significant effect on people's daily lives. But with the recent emphasis on the importance of evidence-based medical practice, how do we assess this impact? What validated tools are available to measure the effect of AMD-related vision loss in our patients?
Several instruments have been developed to assess VR-QOL: the 14-question Visual Function Index (VF-14),6,7 the 51-item National Eye Institute Visual Function Questionnaire (NEI VFQ),8 and a shorter version of the NEI VFQ (NEI VFQ-25),9 which was developed to reduce the burden of testing on subjects and administrators (see sidebar, Sample Questions from the NEI VFQ-25). The NEI questionnaires have been validated for use in assessing VR-QOL across a spectrum of eye diseases, including retinal diseases, and the shortened NEI-VFQ-25 is now in wide use.
These and similar instruments have been used to document change or lack of change in VR-QOL related to a number of therapies for AMD.
VR-QOL AND AMD TREATMENTS
In the Submacular Surgery Trials, investigators using a short form of the NEI VFQ noted better health-related QOL outcomes in patients in the surgery arm of the trial relative to those in the observation arm.10 There was, however, no difference in visual acuity outcomes in the surgery and observations arms of the trial, so the improvement in QOL in the surgery arm is difficult to interpret.
Macular translocation with 360° peripheral retinectomy resulted in an improvement of QOL as measured with the NEI VFQ-25.11 Greater improvement in QOL from preoperative to 1 year postoperative was seen in patients with greater improvement in scores on the NEI VFQ-25. There was no control arm in the study. Despite the lack of a control arm, this was the first study to document an improvement in QOL associated with the effects of a treatment specifically for AMD.
QOL improvement has also been shown with the use of vision rehabilitation services by patients with low vision from a number of causes.12 In a study of 156 patients (including 55% with AMD), low-vision services were associated with improvement in functional status in 99% of patients, as measured using the VF-14 and the full NEI VFQ.
PHARMACOLOGIC AMD THERAPIES AND VR-QOL
Three pharmacologic agents have received US Food and Drug Administration approval for the treatment of neovascular AMD since 2000: verteporfin photodynamic therapy (Visudyne; Novartis Ophthalmics, East Hanover, NJ) in 2001, pegaptanib intravitreal injection (Macugen; OSI/Eyetech, New York, NY) in 2004, and ranibizumab intravitreal injection (Lucentis; Genentech Pharmaceuticals, South San Francisco) in 2006. Each of these therapies received regulatory approval based on safety and visual acuity results in clinical trials.13,14,15
In the MARINA trial, the effects of ranibizumab on VR-QOL were assessed. Investigators administered the NEI VFQ-25 to patients at the time of the first injection and at 1, 2, 3, 6, 9, 12, 18, and 24 months. The MARINA investigators have assessed the mean change in NEI VFQ-25 scores at 12 and 24 months. A paper describing these results has been submitted to a major peer-reviewed ophthalmic journal, and publication is pending.16
In this analysis, improvements in near-vision, distance-vision, and dependence subscales in the MARINA treatment arms were all noted to be both statistically and clinically significant in comparison to the control arm. This analysis represents the first documentation of improvement in VR-QOL following treatment with pharmacologic agents for any retinal disease. Of even greater importance is that the treatment effect on VR-QOL was witnessed even when the worse-seeing eye was the treated eye (ie, the untreated eye had better than 20/30 visual acuity). This documented improvement validates the clinical impression clinicians have noted that improvement in macular function in either eye will improve a patient's visual function.
Given the significant improvement in visual acuity that was documented in the MARINA trial (the mean change in visual acuity at 24 months was an improvement of 6.6 letters in the 0.5-mg treatment arm vs a mean loss of 14.9 letters in the placebo arm), it is hoped that the treatment will continue to reflect an associated improvement in VR-QOL for patients. And, hopefully, improvement in VR-QOL measures in will become a new norm with this and future AMD therapies.
Depression Increases in Those With AMD, Treatments Show Promise
The literature indicates that there is a fairly high prevalence of depression among patients with age-related macular degneration (AMD). According to a literature review1 the incidence is about 30%. Depression is a major cause of disability among patients with AMD, even when the severity of vision loss is considered. Clearly, this has serious consequences for these patients' quality of life.
Brody et al2 looked at the prevalence of depressive disorders among community-dwelling adults with advanced AMD and the relationship between depression, visual acuity, the number of comorbid medical conditions, disability caused by vision loss as measured by the National Eye Institute Vision Function Questionnaire (NEI VFQ) and the vision-specific Sickness Impact Profile (SIPV), and disability caused by overall health status as measured by the sickness Impact Profile-68 (SIP).
The authors analyzed cross-sectional baseline data from a randomized clinial trial. The participants were 151 adults aged ≥60 years with advanced AMD whose vision was 20/60 or worse in their better eye. The patients were interviewed using measures of depression, disability, and chronic medical conditions. Visual acuity was obtained. Measures used in addition to the ones previously mentioned included the Diagnostic and Statistical Manual of Mental Disorder (DSM-IV) Structured Clinical Interview for DSM-IV (SCID-IV) and the Geriatric Depression Scale (GDS).
Of the patients, 32.5% met SCID-IV criteria for depressive disorder, twice the rate observed in previous studies of community-dwelling elderly. Over and above depression, the authors wrote, visual acuity aided in prediction of the level of vision-specific disability.
They concluded that, depressive disorder is a significant problem for the elderly with AMD and that further research on psychopharmacologic and psychotherapeutic interventions for these patients is warranted to improve depression and enhance functioning. Treatment strategies that teach patients to cope with vision loss should be developed and evaluated, they added.
University of California, San Diego Shiley Eye Center researchers found that a 12-hour self-management program for individuals with advanced AMD leads to lasting improvements in mood and function, especially in depressed patients, and decreases the development of clinical depression in AMD patients over time.3
In this study, individuals who participated in a structured group session designed to educate patients and assist them with skills to successfully live with the vision loss caused by AMD were assessed 6 months after they completed the program.
Benefits of reduced distress and improved function were still seen in those who had participated in the self-management program compared with the control group. The incidence of depression in the control group had grown to more than twice that of the self-management group, indicating that the program "seemed to have a remarkable influence on preventing new cases of depression," according to the study's authors.
For this study, 231 volunteers ranging in age from 60 to 99 years, all with advanced AMD, were randomly assigned to either the self-management group, a group that listened to lectures on tape, and a group that was placed on a waiting list but received no intervention. All patients were assessed for emotional and functional status; about 24% of the patients had major or minor depression.
The 86 patients who participated in the self-management program attended six 2-hour sessions designed "to increase patients' expectations of successfully dealing with the effects of advanced AMD," according to the study's authors. "Low-vision aids and services were discussed. Problem-solving skills training, including goal setting, action plans, new ways to think about their situations, role playing, and modeling of the behaviors to be changed, was provided in an enjoyable and stimulating manner." The program also teaches exercises specially designed for AMD patients to build confidence in their physical abilities.
Even after 6 months, the data indicate that this relatively simple intervention may protect against depression that often occurs in AMD patients, and improves the AMD patients' function, self-efficacy and emotional status, compared with the control patients in the two other groups.
Barry Rovner, MD, was recently awarded $2.4 million by the National Institute of Mental Health to evaluate the efficacy of Problem Solving Treatment (PST), a type of cognitive behavioral therapy, to prevent depression among older people with AMD.4 Dr. Rovner is Professor of Psychiatry and Human Behavior, Jefferson Medical College and Medical Director of Jefferson's Geriatric Psychiatry Program at Wills Eye Hospital in Philadelphia.
According to Dr. Rovner, it is important to prevent depression from ever happening, as once it sets in, the affective and cognitive experiences are difficult to expel. Also, depression can precipitate new or exacerbate preexisiting medical conditions.
According to the Thomas Jefferson University Hospital Web site,4 Dr. Rovner is studying PST because most older people prefer psychosocial over pharmaceutical treatments for depression. PST is an effective treatment for depression, is brief, and can be administered by nonmental health professionals. Its basic premise is that inaccurate appraisals of problems and/or difficulty generating or effectively implementing adaptive solutions can lead to poor coping and depression. PST emphasizes finding practical ways to find solutions to everyday-life problems, according to Dr. Rovner. During therapy, patients are taught to: define their problems, generate possible solutions, choose the best course of action, and implement and evaluate their solutions.
In Rovner's 5-year clinical trial, 230 AMD patients will be randomized into either a usual-care control group or a treatment group. Those in the treatment group will be visited in their homes weekly for 6 weeks by a nurse who will perform PST. In-home assessment of depression, physical function, visual acuity, vision function, quality of life, and physical health will be performed at 2, 6, and 12 months postbaseline by a geriatric psychiatric nurse.
The aims of the study are to test the efficacy of PST to reduce the incidence of depressive disorder by 6 months, and to determine whether PST has beneficial effects on function and vision-related quality of life at 6 months, compared with the control group.
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