Macula Vision Research Foundation
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Macular Degeneration 101
You Should Know
- Anatomy of the Eye
- Treatment - What works?
- Lucentis
- Laser
- Photodynamic Therapy
- Nutrition The AREDS Study
- Low Vision Rehabilitation
- Clinical Trials
- Who is affected when someone has macular degeneration?
- Macular Degeneration as a Public Health Issue
- Impact of macular degeneration
- What Does the Public Know About Macular Degeneration?
Anatomy of the Eye
Treatment - What works?
DRY 90% of cases - no treatment
WET 10% of cases
Lucentis
The U.S. Food and Drug Administration (FDA) recently approved Lucentis™ (ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration (AMD). Wet AMD accounts for approximately 10% of the cases of macular degeneration, but it is the most severe form of the disease in terms of loss in central vision. Individuals with dry AMD are at risk for developing the wet form. Wet AMD is caused by the development of abnormal blood vessels in the central or macula region of the retina. These blood vessels can leak causing macular scarring and permanent loss in central vision.
Lucentis developed by Genentech is an antibody fragment that binds to VEGF-A, a protein that is required for blood vessel formation. This interaction prevents VEGF-A from binding to receptors on the surface of endothelial cells and as a result new blood vessels can not form. In results of two large Phase III clinical trials, 95% of patients with wet AMD receiving monthly intravitreal injections of Lucentis showed no significant visual loss over a 2 year period, while up to 40% of the individuals showed measurable improvement in vision over this time period. Importantly, this is the first time that a treatment for AMD has increased rather than simply stabilizing the vision of some affected individuals.
Lucentis is a humanized monoclonal antibody derived from Avastin (bevacizumab) which was also developed by Genentech and approved by FDA for the treatment of colon cancer. One injection of Lucentis is expected to cost about $1950 with monthly injections required for maximum benefit. Avastin is over 100 times less expensive than Lucentis. However, to date there have been no systematic studies reported comparing Lucentis with Avastin for wet AMD.
The successful clinical trials reported for Lucentis is a break-through in the development of treatments for wet AMD and offers hope for stabilizing and in some cases improving the vision of individuals experiencing progressive vision loss. AMD is the leading cause of legal blindness in the U.S. for individuals over the age of 55. The number of people affected by AMD is expected to increase substantially in the future as individuals live longer and are exposed to environmental insults. The development of Lucentis as a treatment for AMD is a clear example of the benefits of basic and clinical research for the treatment of eye diseases.
Laser
Treatments for age-related macular degeneration are limited. Laser treatment is the only proven treatment, to date, to stop age-related macular degeneration.
The Macular Photocoagulation Study (MPS), sponsored by the National Institutes of Health, was a multi-center study. It investigated the use of laser photocoagulation in treating patients, in the early stages of the disease, who had new blood vessel growth under the macula resulting in the loss of sharp central vision. The MPS definitely determined that the use of the laser treatment was beneficial in halting or slowing the progress of age-related macular degeneration. However, it cannot restore lost vision. Despite good visual results from laser photocoagulation, the laser treatment sometimes damages the overlying retina and the blood vessels tend to reappear in about 50% of the cases. However, the treatment is only useful for patients with severe "wet" macular degeneration-about 10% of the total number of people diagnosed with age-related macular degeneration.
We do not yet know what stops or stimulates blood vessel growth within the eye. Blood vessel growth is positive in all other parts of the body. However, we wish to learn how to stop blood vessel growth in the eye to prevent macula vision loss.
Photodynamic Therapy
In April, 2000, the US Drug Administration approved the first drug to treat AMD. It treats abnormal blood vessels under the retina by combining a photosensitizing, light-activated drug injected into a vein. The drug is quickly absorbed by the fast growing "bad" blood vessels in the eye. A low-power red laser beam can then be aimed directly at the highlighted blood vessels in the eye. The therapy arrests or slows the leakage of the abnormal vessels in the eye without damaging the retina and stabilizes vision for a while. Re-treatment is often necessary because the blood vessels tend to grow back.
Low Vision Rehabilitation
Research shows that millions of people are partially sighted and that no more than two percent use any type of low vision rehabilitation service. This type of treatment can make a difference to people's daily lives. Optical aids may include microscopic lenses, special magnifiers, closed circuit television, computer systems and telescopes. Non-optical aids include large-print reading materials, writing guides, household helpers and games. A good example is the use of bold large-print playing cards for those who thought that they had to give up playing bridge, pinochle, etc. as well as the companionship that games can offer.
Vision rehabilitation services can help to prevent falls, burns, and other injuries and can positively impact healthy behaviors in diet, exercise, hobbies, and disease management.
The Alliance for Aging Research identifies vision impairment as one of the four leading causes of lost independence among older people. There is probably nothing more important that one person can do for another than to help with new information, education and the ability to increase one's dignity and self-worth. The suggestion of Low Vision Rehabilitation can make a positive difference in the life of someone with macular degeneration.
Clinical Trials
Research continues to discover the cause, treatment, prevention and cure for macular diseases. Most discoveries that have advanced medical science and aided the war against disease have followed the same path:
- Researchers make a discovery in the laboratory
- Researchers investigate the potential applications of the discovery
- Researchers conduct test applications, usually on animal models
- If the test applications are successful, researchers move forward to clinical trials. A clinical trial is the way new treatments are tested on people. A clinical trial can be conducted for a new drug, a new surgical treatment or radiation therapy. The trials are performed in an effort to determine whether the human body can withstand the drug or treatment. These trials are called Phase I and Phase II trials.
- Phase I assesses the treatment's safety. It's usually the first time the treatment is used for humans, based on the benefits of the treatment on animals or laboratory studies.
- Phase II studies examine the treatment to see whether it is effective.
- The next test, Phase III trials, is a comparative study of a new treatment against the older, standard treatment or a placebo (if there is no standard treatment). Phase III studies are conducted because there are indications that the new treatment may have an advantage over the one being used; examine whether the drug or treatment produces the hoped for therapeutic benefits. The studies are randomized, which means the participants are randomly assigned to receive either the standard treatment or new treatment.
- Phase IV occurs after the medication or treatment has been approved by the Food and Drug Administration and is available to the public. This phase provides information concerning long-term effectiveness and side effects.
All such trials, conducted in the United States, require federal approval and oversight. For each remarkable discovery that makes the successful journey from laboratory to the patient, thousands of projects are stopped when the experiments disprove the fundamental assumption, cause injury or are unable to produce the desired therapeutic effects.
According to a study in the British Medical Journal, clinical trials can be partially credited with producing three of the seven years of increased life expectancy seen in the last half century, as well as five years of improved quality of life among people with chronic medical problems.
Who is affected when someone has macular degeneration?
The personal tragedy and suffering that comes with having macular degeneration is very difficult to understand. It robs people of their ability for personal independence. To depend on someone to read everything for you, take you everywhere you want to go, hold your arm so that you do not trip or fall...the list is never-ending. The other people affected when a family member or friend has macular degeneration are all of the family members and friends who must help, shop, drive, manage affairs and take care of the affected person.
Macular Degeneration as a Public Health Issue
Impact of macular degeneration
As the graying of America increases, macular degeneration becomes an even more important public health issue. The impact of the large number of people suffering from vision loss, due to age-related macular degeneration, on their quality of life and the cost of health-care and social services will have great ramifications.
The emphasis on Social Security in the last presidential campaign reflected the growing awareness that in only a decade millions of baby boomers will give America a greatly increased population over 65. Unprecedented rates of longevity and better healthcare will mean that this group of Americans will not only be larger but will live longer than those before them.
Macular degeneration affects about 15 million people:
- Over 1.6 million people have late age-related macular degeneration (significant impairment).*
- 1 in 4 (25%) of Americans over age 65 have macular degeneration
- 1 in 3 (33%) of Americans over age 80 have macular degeneration.
- By the year 2030, it is projected that the number of people with macular degeneration will double and could affect as many as 42 million Americans.
* "Vision Provlems in the U.S." Prevent Blindness America. National Eye Institute. National Institutes of Health, 2002
The projections seem to indicate a public health problem in the future. As the record number of Americans, born between 1946 and 1964 reach retirement and take advantage of Medicare and other health programs, the cost of their care can overwhelm federal budgets. Loss of vision can have dramatic consequences in terms of disability and greater healthcare expenditures.
Scientists still do not know exactly what causes the vision loss or how to treat or cure macular degeneration. Many studies are underway to discover its origin, prevention, treatment and cure.
If we choose to make the right investments in research, life for the elderly can be not only longer but also healthier and richer in opportunities and pleasure. We seem to be on the verge of solutions to the age-related decline in vision, however, our conversation must move from discussing how to care for people with age-related macular degeneration to funding the research that will bring the prevention and yes, the cure for this debilitating disease. We want to redesign our older age.
Fourteen million baby boomers have the potential to claim Social Security and to develop macular degeneration. The loss of a loved one's central vision from this disease places financial burdens on sufferers and family members who sacrifice their own health, savings and resources to care for them.
What Does the Public Know About Macular Degeneration?
Macular degeneration is the most common cause of severe vision loss among people over 65, and, as life expectancy increases, the disease is becoming an increasingly important problem.** The AMD Alliance International, a non-profit association, commissioned a survey to determine knowledge about age-related macular degeneration (AMD). The survey was conducted in May, 1999, among representative samples of 6,951 adults, aged 18 and older, in Canada, France, Germany, Italy, Spain, the United States and the United Kingdom.***
The following information from the survey is reported with permission.
| Where Do We Get Our Information About AMD? | |
|---|---|
| 26% | in the United States learned the most from personal contacts (friend, family members, co-worker, someone who has AMD) |
| 21% | said their source of knowldege was a newspaper or magazine story or ad |
| 17% | learned about AMD from a doctor or other medical professional |
| How Often Do You Have An Eye Examination? | |
|---|---|
| 10% | reported having their eyes examined more than once a year |
| 38% | have eye examinations once a year |
| 25% | have eye examinations once every five years, or less frequently |
| 6% | have eye examinations every three years |
| 3% | every four years |
| 12% | every five years |
| 7% | never |
(Interestingly, the percentage of examinations did not change substantially between income categories.)
| What Do You Think Is the Main Purpose for Having An Eye Examination or Eye Test? | |
|---|---|
| 36% | thought the main purpose of an eye examination was to check the general health of the eye |
| 17% | said the general purpose of an eye examination was to detect eye disease at an early stage |
| 38% | related the need for eye examinations to determine whether glasses were needed or a change of prescription was necessary |
| 7% | Other |
Survey conducted by the the AMD Alliance Internations. Conducted among representative samples of 6,952 adults in Candada, France, Germany, Italy, Spain, U.S. and U.K., May 1999. Interviews conducted in the U.S. by Opinion Research Corporation International (ORCI) and in Canada and Europe by IPSOS.
*Source: Prevent Blindness America 2001
**Dictionary of Eye Terminology Fourth Edition, 2001 by Barbara Cassin and Melvin L. Rubin, MD, Editor
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This animation shows the degenerative changes to the macula. A dark area, or black out, may appear in the center of vision, but peripheral vision often remains clear.