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Macular Degeneration in One Eye Associated with Increased Incidence and Progression in the Other Eye

Photograph of a retina with wet age-related macular degeneration

A new study has investigated the pattern and progression of wet (also called neovascular) including age-related macular degeneration (AMD), and determined that having wet AMD in one eye was associated with an increased incidence and progression of AMD in the other eye.

The researchers concluded that "AMD severity in one eye largely tracks AMD severity in the 'fellow' eye at all stages of the disease." The study results clarify the symmetrical nature of AMD and may help physicians and patients communicate more clearly when discussing the course and prognosis of AMD.

From JAMA Ophthalmology

The research, entitled Severity of Age-Related Macular Degeneration in 1 Eye and the Incidence and Progression of Age-Related Macular Degeneration in the Fellow Eye: The Beaver Dam Eye Study, was published "online first" in the October 23, 2014 edition of JAMA Ophthalmology (formerly Archives of Ophthalmology). JAMA Ophthalmology is an international peer-reviewed journal published monthly by the American Medical Association.

The authors are Ronald E. Gangnon, PhD; Kristine E. Lee, MS; Barbara E. K. Klein, MD, MPH; Sudha K. Iyengar, PhD; Theru A. Sivakumaran, PhD; and Ronald Klein, MD, MPH, who represent the following institutions: the University of Wisconsin School of Medicine and Public Health, Madison; Case Western Reserve University, Cleveland, Ohio; and Cincinnati Children's Hospital Medical Center, Ohio.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is gradual, progressive, painless deterioration of the macula, the small sensitive area in the center of the retina that provides clear central vision. Damage to the macula impairs the central (or "detail") vision that helps with essential everyday activities such as reading, preparing meals, watching television, playing card and board games, and sewing.

AMD is the leading cause of vision loss for people aged 60 and older in the United States. According to the American Academy of Ophthalmology, 10-15 million individuals have AMD and about 10% of people who are affected have the "wet" type of AMD.

Wet (Neovascular) Macular Degeneration

In wet, or exudative, macular degeneration (AMD), the choroid (a part of the eye containing blood vessels that nourish the retina) begins to sprout abnormal new blood vessels that develop into a cluster under the macula, called choroidal neovascularization (neo = new; vascular = blood vessels).

The macula is the part of the retina that provides the clearest central vision. Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid under the macula, causing it to lift up and pull away from its base. This damages the fragile photoreceptor cells, which sense and receive light, resulting in a rapid and severe loss of central vision.

Risk Factors for Macular Degeneration

The primary risk factors for AMD include the following:

  1. Smoking: Current smokers have a 2-3 times higher risk for developing AMD than do people who never smoked. It's best to avoid second-hand smoke as well.
  2. Sunlight: Ultraviolet (UV) light is not visible to the human eye, but can damage the lens and retina. Blue light waves that make the sky, or any object, appear blue, are visible to the human eye and can also damage the lens and retina. Living Well with Low Vision reports on these lighting issues in Artificial Lighting and the Blue Light Hazard. Avoid UV light and blue/violet light as much as possible by wearing sunglasses with an amber, brown, or orange tint that blocks both blue and UV light.
  3. Uncontrolled hypertension: The National Eye Institute (NEI) reports that persons with hypertension were 1.5 times more likely to develop wet macular degeneration than persons without hypertension. It's important to keep your blood pressure controlled within normal limits.
  4. A diet high in packaged, processed food and low in fresh vegetables: NEI suggests that eating antioxidant-rich foods, such as fresh fruits and dark green leafy vegetables (kale, collard greens, and spinach) may delay the onset or reduce the severity of AMD. Eating at least one serving of fatty fish (salmon, tuna, or trout) per week may also delay the onset or reduce the severity of AMD.
  5. Race: According to NEI, Whites/Caucasians are more likely to have AMD than people of African descent.
  6. Family history: NEI reports that individuals with a parent or sibling with AMD have a 3-4 times higher risk of developing AMD.

You can read more about the full range of AMD risk factors at Risk Factors for Age-Related Macular Degeneration on the VisionAware website.

About the Beaver Dam Eye Study

The Beaver Dam Eye Study is funded by the National Eye Institute. The purpose of the Study is to collect information on the prevalence and incidence of age-related cataract, macular degeneration, and diabetic retinopathy, which are all common eye diseases causing loss of vision in an aging population. The study was designed to discover, or detect, causes of these conditions.

The study also has examined other age-related issues, including decline in overall health and quality of life and development of kidney and heart disease.

The study was initially funded in 1987. A private census conducted in the city and township of Beaver Dam, Wisconsin found that there were approximately 6,000 people aged 43 through 84 years. Approximately 5,000 of them participated in the baseline examination between 1988 and 1990.

Five-, 10-, 15-, and 20-year follow-up examinations have taken place and 3,700, 2,800, 2,100, 2,000, and 1,900 people participated in each of the respective examination phases. Thus far, there have been more than 300 publications describing the prevalence and incidence of visual loss, age-related macular degeneration, cataract, and associated risk factors as a result of this study.

You can read more about the study at the Beaver Dam Eye Study website.

About the Research

Excerpted from Progression of age-related macular degeneration in one eye then fellow eye via Medical Xpress:

Having age-related macular degeneration (AMD) in one eye was associated with an increased incidence of AMD and accelerated progression of the debilitating disease in the other eye, writes author Ronald E. Gangnon, Ph.D., of the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues.

AMD is thought to be a symmetric disease, although one eye may precede the other in progression.

The authors examined the effect of severity of AMD in one eye on the incidence, progression and regression in the other eye. Data from 4,379 participants in the Beaver Dam Eye Study were used. Retinal photographs were used to assess the incidence, progression, and regression of AMD.

While more severe AMD in one eye was associated with increased incidence and accelerated progression in the other eye, less severe AMD in one eye was associated with less progression in the other eye.

"In a [patient group] that was observed for 20 years, we showed that AMD severity in one eye largely tracks AMD severity in the fellow eye at all stages of the disease. ... Our model demonstrated the effect of one eye on the incidence and progression of AMD in its fellow eye across the entire continuum of AMD severity."

More about the Study from JAMA Ophthalmology

From the article abstract:

Importance: Previous studies regarding the severity of age-related macular degeneration (AMD) in 1 eye and its prognostic implications for the fellow eye have focused on the incidence of neovascular AMD in the fellow eye of participants with neovascular AMD in the other eye. It is unclear to what extent the severity of AMD in 1 eye affects the incidence, progression, and regression of AMD in its fellow eye across the entire range of AMD severity.

Objective: To investigate the effect of the severity of AMD in 1 eye on the incidence, progression, and regression of AMD in the fellow eye.

Design, Setting, and Participants: The Beaver Dam Eye Study is a longitudinal population-based study of age-related eye diseases conducted in the city and township of Beaver Dam, Wisconsin. Examinations were performed every 5 years over a 20-year period (from the baseline examination in 1988-1990 to 2008-2010). Study participants (4,379) were 43 to 86 years of age at the baseline examination. At baseline and in up to four subsequent examinations, retinal photographs were taken.

[Note: A longitudinal study follows, and gathers information about, the same individuals or group of people over an extended period of time – often many decades.]

Results: More severe AMD in 1 eye was associated with increased incidence of AMD and accelerated progression in its fellow eye. Less severe AMD in 1 eye was associated with less progression of AMD in its fellow eye. We estimate that 51% of participants who develop any AMD always maintain AMD severity states within 1 step of each other between eyes; 90% of participants stay within 2 steps.

Conclusions and Relevance: Using multistate models, we show that AMD severity in 1 eye tracks AMD severity in its fellow eye.

Additional Information


Topics:
Medical Updates
Macular Degeneration

Adult Stem Cells for Dry AMD: Emerging Future Research from the National Eye Institute

A retinal photograph of dry AMD

One of the most significant challenges facing eye and vision researchers is the development of an effective treatment for dry age-related macular degeneration (AMD). Although there are now a number of well-regarded FDA-approved drug treatments for wet AMD, the key to effective dry AMD treatment remains elusive thus far, although several promising treatments have entered clinical trials.

Current treatments for dry AMD include a number of non-drug-related measures, including (a) nutritional supplements recommended by the Age-Related Eye Disease Study 2 (AREDS2), and (b) controlling a range of lifestyle factors, including diet, weight, blood pressure, smoking, and ultraviolet light exposure.

Stem Cell Treatments and Dry AMD

This month, information about two preliminary – but promising – stem cell treatments for dry AMD has been released to the public.

1. Advanced Cell Technology: Human Embryonic Stem Cells

On October 14, 2014, Advanced Cell Technology, Inc. announced positive results from its small (18-patient) early-stage clinical trials of human embryonic stem cells (hESC) for the treatment of dry AMD and Stargardt disease.

The research uses retinal pigment epithelial (RPE) cells derived from human embryonic stem cells. These cells are created by taking stem cells from a days-old embryo created in a fertility clinic and inducing the embryonic cells to differentiate into more specialized cells, such as RPE cells.

[Editor's note: The deepest cells of the retina comprise the retinal pigment epithelium (RPE). The RPE helps to maintain the health of the retinal photoreceptor cells, called rods and cones. These photoreceptor cells are triggered by light to set off a series of electrical and chemical reactions that helps brain to interpret what the eye sees. The degeneration of the RPE cells also leads to the death of the rods and cones and, ultimately, vision.]

Although the primary goal of this small early-stage clinical trial was to assess the safety of the transplanted stem cells, the treatment also had unexpected positive benefits: Ten out of 18 study participants reported improvements in vision, with some subjects reporting dramatic improvements. In addition, the treatment appears to have halted the progression of the disease in 17 of the 18 subjects.

You can read more about the ACT clinical trial at Positive Stem Cell Clinical Trial Results for Stargardt Disease and Dry Macular Degeneration.

2. Cellular Dynamics International: Induced Pluripotent (Adult-Derived) Stem Cells

On Monday, October 27, Cellular Dynamics International (CDI) announced that the National Eye Institute (NEI) awarded the company a $1.2 million contract to manufacture clinically compatible induced pluripotent stem cells (iPSCs) and iPSC-derived human retinal pigment epithelial (RPE) cells.

These cells will be manufactured from individuals with dry AMD and are intended to be used for Investigational New Drug (IND) studies. If CDI's Investigational New Drug Application is approved by the United States Food and Drug Administration (FDA), the procedure will be used to generate iPSC-derived RPE tissue for transplantation back into the same patients. This process, known as autologous cellular therapy (i.e., involving one individual as both donor and recipient) would be the first of its kind permitted in the United States.

Current Retinal Stem Cell Research in the United States and Japan

On November 22, 2010, the U.S. Food and Drug Administration (FDA) lifted a prior clinical hold on stem cell research to clear Advanced Cell Technology's (ACT) Investigational New Drug application and initiate a Phase 1/2 clinical trial, using retinal cells derived from human embryonic stem cells (hESC) to treat patients with Stargardt disease. On January 3, 2011, ACT received FDA clearance for another new clinical trial using hESCs to treat dry AMD.

To date, the FDA has not yet cleared/approved stem cell research using adult/autologous iPSCs for clinical trials for eye disease, including dry AMD; thus, the Cellular Dynamics stem cell product will require FDA approval of its Investigational New Drug application before it can proceed into clinical trials.

In September 2014, researchers in Kobe, Japan used iPSC techniques and technology to transplant retinal cells, developed from a 70-year-old woman's skin, into one of her eyes. According to the Wall Street Journal blog, Japanese researchers stress that "the current study is a type of pretrial research under Japanese regulations that can't immediately lead to approved therapies or commercialization."

Although adult/iPSC research does not use human embryos and thus sidesteps the ethical issues surrounding their use, there are still significant risks associated with the use of autologous stem cells, including tumor formation.

About Dry Macular Degeneration

The dry (also called atrophic) type of AMD affects approximately 80-90% of individuals with AMD. Its cause is unknown, it tends to progress more slowly than the wet type, and there is not – as of yet – an approved treatment or cure. "Atrophy" refers to the degeneration of cells in a portion of the body; in this case, the cell degeneration occurs in the retina.

In dry age-related macular degeneration, small white or yellowish deposits, called drusen, form on the retina, in the macula – the small sensitive area in the center of the retina that provides clear central vision – causing it to deteriorate or degenerate over time.

Photograph of a retina with drusen

A retina with drusen

Drusen are the hallmark of dry AMD. These small yellow deposits beneath the retina are a buildup of waste materials, composed of cholesterol, protein, and fats. Typically, when drusen first form, they do not cause vision loss. However, they are a risk factor for progressing to vision loss.

More about the Cellular Dynamics Announcement

From Cellular Dynamics International awarded National Eye Institute contract, via the Journal-Sentinel:

Cellular Dynamics International Inc. (CDI), a … maker of human cells in industrial quantities, said … it has received a $1.2 million contract from the National Eye Institute (NEI) – the company's first agreement to manufacture its cells for therapeutic use.

Under the contract, CDI would take blood or tissue from 10 patients with [dry age-related macular degeneration], turn some of it into stem cells, then further program those cells to become retina cells.

NEI researchers plan to use these cells as part of their pre-clinical process to develop the first autologous cell transplantation treatment for dry AMD. The cells are expected to be injected in about three years into the 10 patients in the trial.

The process, known as autologous cellular therapy, would likely be the first of its kind in the U.S., CDI said. Since the cells would genetically match the patient, the expectation is that the risk of transplant rejection would be reduced.

Kapil Bharti, Ph.D., a Stadtman Investigator in the Unit on Ocular and Stem Cell Translational Research at NEI, will be the lead researcher on the stem cell project. VisionAware will provide updates on this emerging stem cell research as they become available.

Additional Information


Topics:
In the News
Medical Updates
Clinical Trials
Macular Degeneration

What's So Wrong with "Elderspeak," Anyway? Answer: Everything

Hypocorisma: It's the bane of older adulthood. What is hypocorisma, you ask? Here is a helpful (and perceptive) definition from Maeve Maddox at the excellent Daily Writing Tips blog:

profile of a person with gray hair

Hypocorisma is a type of euphemism derived from a Greek word meaning "pet name." The English word hypocorism may be defined as "the diminutive or otherwise altered version of a given name."

The use of diminutives and pet names is usually an indication of affection or intimacy, but sometimes hypocorisma is used to diminish, infantilize, or insult. For example, the same words used as endearments by family members and close friends are seen as insulting when they come from strangers.

A friendly "Hon" to frequent customers in a local restaurant is one thing, but in the workplace in general, employees, customers, and healthcare workers would be wise to avoid terms of endearment, especially when dealing with a segment of the population that is bombarded with such empty endearments.

People in their seventies and above are so often addressed in nursery language that researchers have a word for this type of hypocorisma: elderspeak.

The University of Kansas: Elderspeak and Resistance to Care

In addition to being annoying, infantilizing, disrespectful, and demeaning, elderspeak can have additional – and far more serious – deleterious effects as well. Doctors Ruth Herman and Kristine L. Williams from the University of Kansas School of Nursing explored the effects of elderspeak in the American Journal of Alzheimer's Disease & Other Dementias.

Their study, entitled Elderspeak's Influence on Resistiveness to Care: Focus on Behavioral Events, concluded that:

Resistiveness to care in older adults with dementia commonly disrupts nursing care. Research has found that elderspeak (infantilizing communication) use by nursing home staff increases the probability of resistiveness to care in older adults with dementia.

We found that older adults with dementia most frequently reacted to elderspeak communication by negative vocalizations (screaming or yelling, negative verbalizations, crying).

Because negative vocalizations disrupt nursing care, reduction in elderspeak use by staff may reduce these behaviors, thereby increasing the quality of care to these residents.

Elderspeak in Rehabilitation

As a vision rehabilitation therapist and low vision therapist whose specializes in the rehabilitation needs of older adults with vision loss, I am particularly attuned to the negative effects of elderspeak/hypocorisma. All too often, when working with older adults in community-based settings and in long-term care, I have heard the following statements – likely intended as endearments, but infantilizing nonetheless:

  • "Hello, Mary dear. Maureen is here to see you. And how are we doing today, sweetie?"
  • "You're looking for Martha? She's in the day room. You know, we just love Martha – she's such a sweetheart. She never gives us any trouble."
  • "Ah, Thomas. He's such a sweetheart. We all love him. But I'm not sure you'll be able to do anything with him – he's blind, you know."

Soul-crushing, isn't it? I cringe when I experience such statements: ostensibly well-intentioned, but ultimately deadening. And yes, I have been called "Hon" many times when delivering vision rehabilitation services in these settings. (In case you're wondering, I am the polar opposite of sweet, demure, and accommodating.)

The New York Times Examines Elderspeak

Thus, I found it heartening to read a serious examination of the "elderspeak problem" in The New York Times. Throughout the article, entitled In 'Sweetie' and 'Dear,' a Hurt for the Elderly, author John Leland systematically debunks this infantilizing practice and clearly describes its negative effects on both quality of life and life expectancy:

Professionals call it elderspeak, the sweetly belittling form of address that has always rankled older people: the doctor who talks to their child rather than to them about their health; the store clerk who assumes that an older person does not know how to work a computer, or needs to be addressed slowly or in a loud voice. Then there are those who address any elderly person as "dear."

Now studies are finding that the insults can have health consequences, especially if people mutely accept the attitudes behind them, said Becca Levy, an associate professor of epidemiology and psychology at Yale University, who studies the health effects of such messages on elderly people.

"Those little insults can lead to more negative images of aging," Dr. Levy said. "And those who have more negative images of aging have worse functional health over time, including lower rates of survival."

In a long-term survey of 660 people over age 50 in a small Ohio town, published in 2002, Dr. Levy and her fellow researchers found that those who had positive perceptions of aging lived an average of 7.5 years longer, a bigger increase than that associated with exercising or not smoking. The findings held up even when the researchers controlled for differences in the participants' health conditions.

Hello, Sweetie

Despite such research, the worst offenders are often health care workers, said Kristine Williams, a nurse gerontologist and associate professor at the University of Kansas School of Nursing.

To study the effects of elderspeak on people with mild to moderate dementia, Dr. Williams and a team of researchers videotaped interactions in a nursing home between 20 residents and staff members. They found that when nurses used phrases like "good girl" or "How are we feeling?" patients were more aggressive and less cooperative or receptive to care. If addressed as infants, some showed their irritation by grimacing, screaming or refusing to do what staff members asked of them.

Dr. Williams said health care workers often thought that using words like "dear" or "sweetie" conveyed that they cared and made them easier to understand. "But they don't realize the implications," she said, "that it's also giving messages to older adults that they're incompetent." She added that patients who reacted aggressively against elderspeak might receive less care.

Elderspeak and Adult Learning Theory

Closely aligned with the issues surrounding elderspeak is "andragogy," also called adult learning theory: the art and science of teaching adults. Dr. Malcolm S. Knowles (1913-1997), widely considered to be the "Father of Andragogy" in the United States, wrote extensively about how adults learn and the differences between adult and child learning.

One of his sharpest observations regarding the teaching of adults and older adults is also one that took me many years to truly comprehend: "Most teachers of adults have only known how to teach adults as if they were children. Most of what is known about teaching has been derived from experience with teaching children under conditions of compulsory attendance."

Essentially, there are four important differences between andragogy (teaching adults) and pedagogy (teaching children):

  • Self-Concept: A child's self-concept is derived primarily from external sources. In other words, if you ask children to describe themselves, they will likely mention the school they attend, who their siblings are, and where they live. An adult's self-concept, on the other hand, is derived mainly from "internalized" life experiences. If you ask adults to describe themselves, they will likely mention the work they have done and what their life experiences have been.
  • The Role of Experience: To a child, experience is something that happens to her or him. A child is still learning to internalize and use these experiences to learn more about the world. Adults, on the other hand, have accumulated and internalized vast quantities of experience, which provide a rich background for all types of learning. When working with adults, therefore, acknowledge and respect their substantial life experiences through mutual discussion and problem solving. Don't treat adult learners as "blank slates" to be filled with new knowledge that you bring to them.
  • Readiness to Learn: In pedagogy, the teacher usually (but not always, of course) determines when the child is "ready to learn." The teacher decides what will be learned and when this learning will take place. In andragogy, the adult decides when he or she is "ready to learn." In vision rehabilitation, this generally happens when a specific need arises; in other words, the adult needs to know or do something "right now" in order to perform a task more effectively in his or her daily life.
  • Time Perspective: In pedagogy, education is preparation for the future, or information to be stored and finally used "some day." In andragogy, learning is task-centered and involves everyday problems that require more immediate solutions. Therefore, teachers of adults help learners move toward independent self-direction and determine what it is that they need to learn in the present – which may not necessarily be what family members or other professionals want the adult to learn.

So What's the Takeaway?

First, examine your own speech and attitudes for any tendency to use elderspeak. As John Leland says, "Words matter. So does context. Terms of endearment are probably best reserved for the people we hold dear."

Next, if you teach adults and older adults in any capacity, examine your attitudes toward your adult learners. Ask yourself these questions:

  • Has the way you learned as a child affected or had an influence upon your adult professional behavior in education or rehabilitation?
  • Do any of Dr. Malcolm Knowles's descriptions of adult learners describe you?
  • Reflect on a professional issue that you have addressed recently with an adult or older adult. Could you rethink your actions in light of these andragogical principles?

What have I learned after all these years? Essentially, that my role is to "get out of the way." People know what they need to learn. I'm just the facilitator. In truth, I've gone from thinking I knew everything about vision rehabilitation to finally realizing I don't know very much at all. Learning, for me, is a forever process.


Topics:
Cultural Diversity
Personal Reflections

Positive Stem Cell Clinical Trial Results for Stargardt Disease and Dry Macular Degeneration

A retinal photograph of dry AMD

On October 14, 2014, Advanced Cell Technology, Inc. announced positive results from its small (18-patient) early-stage clinical trials of human embryonic stem cells (hESC) for the treatment of dry age-related macular degeneration and Stargardt disease.

Advanced Cell Technology, Inc. (ACT) is a Massachusetts-based clinical-stage biotechnology company focused on the development of regenerative medicine and cell therapy technology. ACT's most advanced products are in clinical trials for the treatment of dry age-related macular degeneration, Stargardt disease, and myopic macular degeneration.

Although the primary goal of this small early-stage clinical trial was to assess the safety of the transplanted stem cells, the treatment also had unexpected positive benefits: Ten out of 18 study participants reported improvements in vision, with some subjects reporting dramatic improvements. In addition, the treatment appears to have halted the progression of the disease in 17 of the 18 subjects.

Please note: Although this stem cell research has produced promising results thus far, it is in its very earliest stages and must be subjected to additional, longer-term, more demanding clinical trials, encompassing many more years of study.

The Research: The Lancet

The Lancet logo

The research, entitled Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: follow-up of two open-label phase 1/2 studies (explained below), has been published online ahead of print in the October 15, 2014 issue of The Lancet.

The Lancet, which has been published continuously for 180 years, is one of the world's leading independent medical journals, without affiliation to a medical or scientific organization. The journal, which is committed to international health concerns, publishes high-quality clinical trials that influence the course of medical practice.

The authors are Steven D. Schwartz, Carl D. Regillo, Byron L. Lam, Dean Eliott, Philip J. Rosenfeld, Ninel Z. Gregori, Jean-Pierre Hubschman, Janet L. Davis, Gad Heilwell, Marc Spirn, Joseph Maguire, Roger Gay, Jane Bateman, Rosaleen M. Ostrick, Debra Morris, Matthew Vincent, Eddy Anglade, Lucian V. Del Priore, and Robert Lanza.

The authors represent the following institutions: Jules Stein Eye Institute and David Geffen School of Medicine, University of California, Los Angeles; Wills Eye Hospital and Thomas Jefferson University, Philadelphia, PA; Bascom Palmer Eye Institute, Miami, FL; Massachusetts Eye and Ear Infirmary and Harvard Medical School, Boston, MA; Advanced Cell Technology, Marlborough, MA; and Storm Eye Institute, Medical University of South Carolina, Charleston, SC.

First, Some Background and History

Since November 2010, VisionAware has followed Advanced Cell Technology's (ACT) quest to implement successful clinical trials for macular eye disease, using human embryonic stem cells. ACT's US Phase 1/2 clinical trials for Stargardt disease and dry age-related macular degeneration (AMD) involved a total of 18 patients, in groups of three (also called cohorts in research terminology). The first group/cohort received a dosage of 50,000 cells; the second received 100,000 cells; and the third received 150,000 cells.

To better understand this latest development, here is background information from prior VisionAware blog posts about ACT's initial stem cell clinical trial for Stargardt disease, its subsequent clinical trial for dry age-related macular degeneration, and a 2013 update about the status of all ACT ongoing clinical trials:

On November 22, 2010, the U.S. Food and Drug Administration (FDA) lifted a prior clinical hold on stem cell research to clear Advanced Cell Technology's Investigational New Drug (IND) application and initiate a Phase 1/2 multicenter study, using retinal cells derived from human embryonic stem cells to treat patients with Stargardt disease. ACT's product is a human embryonic stem cell trained to become a retinal cell.

On January 3, 2011, ACT announced that they had received FDA clearance for yet another new clinical trial, this time using embryonic stem cells to treat dry AMD.

Information about ACT's ongoing clinical trials is available at ClinicalTrials.gov, with the following Identifiers: NCT01345006 (U.S. Stargardt disease) and NCT01344993 (U.S. dry AMD).

More about the Research

From Groundbreaking stem-cell research, via Boston Business Journal:

Advanced Cell Technology (ACT) [has] announced results from an early-stage trial indicating that its treatment helped improve vision in 10 out of 18 patients with two kinds of macular degeneration. ACT's embryonic stem cell-based treatment was administered at least six months ago in all 18 patients, although the median period was 22 months and two of the patients were treated more than three years ago.

[Editor's note: Called retinal pigment epithelial cells, these cells are created by taking stem cells from a days-old embryo created in a fertility clinic and inducing the embryonic cells to differentiate into more specialized cells. You can read more about ACT's proprietary single-blastomere stem cell technology in ACT's February 23, 2011 press release.]

All 18 patients in the Phase 1/2 trial have either Stargardt's macular degeneration, an inherited disorder, or dry age-related macular degeneration, neither of which have any effective treatments on the market today. The patients received a transplant of … retinal pigment epithelium (or RPE) cells, which protect photoreceptors in the eye, using ACT's cells made from embryonic stem cells.

The main goal of the study was to show that process is safe, but the treatment appeared to have stopped progression of the disease in 17 out of 18 of the patients. In addition, the majority of them performed better on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity exam.

the EDTRS eye chart

The ETDRS Eye Chart

The trial data not only represents a victory in eye treatments, it’s also the first evidence of long-term safety, survival, and biologic activity in humans of stem cells in any disease.

More about the Study from The Lancet

From the research summary:

Background: Since they were first derived more than three decades ago, embryonic stem cells have been proposed as a source of replacement cells in regenerative medicine, but their plasticity and unlimited capacity for self-renewal raises concerns about their safety, including tumor formation ability, potential immune rejection, and the risk of differentiating into unwanted cell types. We report the medium-term to long-term safety of cells derived from human embryonic stem cells (hESC) transplanted into patients.

Methods: In the USA, two prospective phase 1/2 studies were done to assess the … safety and tolerability of subretinal transplantation of hESC-derived retinal pigment epithelium in nine patients with Stargardt's macular dystrophy (age >18 years) and nine with atrophic age-related macular degeneration (age >55 years).

Three dose cohorts (50,000, 100,000, and 150,000 cells) were treated for each eye disorder. Transplanted patients were followed up for a median of 22 months by use of serial systemic, ophthalmic, and imaging examinations.

Findings: There was no evidence of adverse proliferation, rejection, or serious ocular or systemic safety issues related to the transplanted tissue. Adverse events were associated with vitreoretinal surgery and immunosuppression. 13 (72%) of 18 patients had patches of increasing subretinal pigmentation consistent with transplanted retinal pigment epithelium.

Best-corrected visual acuity, monitored as part of the safety protocol, improved in ten eyes, improved or remained the same in seven eyes, and decreased by more than ten letters in one eye, whereas the untreated fellow eyes did not show similar improvements in visual acuity.

Vision-related quality-of-life measures increased for general and peripheral vision, and near and distance activities, improving by 16-25 points 3 to 12 months after transplantation in patients with atrophic age-related macular degeneration and 8-20 points in patients with Stargardt's macular dystrophy.

Interpretation: The results of this study provide the first evidence of the medium-term to long-term safety, graft survival, and possible biological activity of [stem cells] in individuals with any disease. Our results suggest that hESC-derived cells could provide a potentially safe new source of cells for the treatment of various unmet medical disorders requiring tissue repair or replacement.

About Clinical Trials

Most clinical trials are designated as Phase 1, 2, or 3, based on the questions the study is seeking to answer:

  • In Phase 1 clinical trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe and effective dosage range, and identify possible side effects.
  • In Phase 2 clinical trials, the study drug or treatment is given to a larger group of people to determine if it is effective and to further evaluate its safety.
  • In Phase 3 studies, the study drug or treatment is given to even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • In Phase 4 studies, after the United States Food and Drug Administration (FDA) has approved the drug, continuing studies will determine additional information, such as the drug's risks, side effects, benefits, and optimal use.

VisionAware will provide updates on this important stem cell research as they become available.

Additional Information about Stem Cell Research


Topics:
Low Vision
In the News
Medical Updates
Clinical Trials
Macular Degeneration

Eye Injury Prevention Month: Halloween, Lady Gaga, and Cosmetic Contact Lenses

Every year, during Eye Injury Prevention Month – and as Halloween approaches – I begin fielding questions from neighbors, friends, and colleagues about the safety of circle (also called "cosmetic" or "costume") contact lenses. For the uninitiated, "circle lenses," which first became popular in Asia approximately ten years ago, are contact lenses that give the wearer a doll-eyed or doe-eyed "innocent" look:

Venus Palermo with circle lenses

Venus Palermo, the "Human Barbie Doll"

What are Circle or Cosmetic Contact Lenses?

Here is more information about circle lenses from Wikipedia:

Circle contact lenses, also known as "big-eye contact lenses" and "circle lenses," are cosmetic contact lenses that make the eye's iris appear larger. They have become a trend in Japan, South Korea, and China, and are largely produced in these countries.

Circle lenses are tinted not only in areas that cover the iris of the eye, but also prominently in the extra-wide outer rim of the lens. The result is the appearance of a bigger, wider iris and creation of an illusion of large eyes.

The lenses are popular among teenagers and young adults. Many people consider circle lens to be a fashion accessory, rather than a medical device.

According to CBS News Medical Correspondent Dr. Jennifer Ashton, circle lenses "…make the eyes look very large, and it's because the contact lens part actually extends beyond the iris or the colored part of the eye and in doing so, makes the eye look a little bit larger. It's purely cosmetic."

An array of multicolored circle lenses

Examples of circle lenses

Lady Gaga and Circle Lenses

As part of my research into the growing popularity of cosmetic contact lenses, I revisited Lady Gaga's Bad Romance video and discovered that she was indeed wearing what appeared to be "anime-style" circle lenses:

Lady Gaga in a still from Bad Romance

But there's a problem: They're illegal in the United States and can cause severe and permanent eye damage. The New York Times was among the first news organizations to address these issues in an article by Catherine Saint Louis, entitled What Big Eyes You Have, Dear, but Are Those Contacts Risky?:

Of all the strange outfits and accessories Lady Gaga wore in her "Bad Romance" video, who would have guessed that the look that would catch fire would be the huge anime-style eyes she flashed in the bathtub?

These lenses might be just another beauty fad if not for the facts that they are contraband and that eye doctors express grave concern over them. It is illegal in the United States to sell any contact lenses — corrective or cosmetic — without a prescription, and no major maker of contact lenses in the United States currently sells circle lenses.

Sites that sell contact lenses approved by the Food and Drug Administration (FDA) are supposed to verify customers' prescriptions with their eye doctors. By contrast, circle lens websites allow customers to choose the strength of their lenses as freely as their color.

A Definitive Statement from the American Academy of Ophthalmology

The American Academy of Ophthalmology (AAO) has repeatedly warned the public about the many risks associated with the use of costume contact lenses during the Halloween party season. From Four Frightening Ways Non-Prescription Costume Contact Lenses Can Ruin Your Vision:

To avoid a real-life Halloween horror story – going blind because of a costume accessory – the American Academy of Ophthalmology is warning the public against wearing costume contact lenses purchased without a prescription. These illegally-sold cosmetic lenses may not be sterile and can cause a host of serious eye problems capable of morphing a fun Halloween night into a nightmare.

Tiger eyes, checkered pupils: Non-prescription decorative lenses (also called cosmetic, costume or plano contact lenses) come in many different patterns and colors.

In 2005, after reports of them causing eye injuries and infections, the FDA classified all contact lenses as medical devices and restricted their distribution to licensed eye care professionals, effectively banning sales of non-prescription contact lenses.

Despite that, these items remain available on the Internet, in convenience stores, and at flea markets. Here are four frightening ways that non-prescription decorative lenses can hurt your eyes:

  1. Scratches: Because over-the-counter lenses are not fitted and sized for the person wearing the contacts, they can easily scrape the outer layer of the eye. The resulting corneal abrasions can cause redness, light sensitivity, discharge, pain, plus the feeling that something is stuck under the eyelid.
  2. Sores: Costume contact lenses can literally create an eye sore called a corneal ulcer, with symptoms similar to corneal abrasions. The ulcers sometimes appear as a white dot on the iris – the colored part of the eye. When the ulcers heal, they can scar over and can in some cases permanently affect vision.
  3. Infections: Both corneal abrasions and ulcers create openings in the eye, making them more vulnerable to bacteria, viruses and amoebas. All of these organisms can cause serious eye infections known as keratitis. Some infections, such as herpes simplex, can be recurring and difficult to eradicate, while a number of bacteria have become resistant to common antibiotics.
  4. Blindness: In the most extreme cases, complications from wearing costume contact lenses may require surgery or end in blindness. For instance, extensive scarring from an infection can distort the cornea or make it opaque, requiring a corneal transplant to restore vision.

Complications from Cosmetic/Costume Contact Lenses

Because most purchases of cosmetic, costume, and circle contact lenses are neither prescribed nor regulated, eye infections are more common than you might think. And infections, in some cases, can lead to blindness. Here are some additional complications that can occur from purchasing online or "over-the-counter" contact lenses:

Cosmetic/Costume Contact Lens Safety Guidelines

To wear decorative contact lenses safely this Halloween, or any time of year, the American Academy of Ophthalmology recommends following these guidelines:

  • Only buy decorative contact lenses from an eye care professional, such as an ophthalmologist or optometrist, or a retailer that requires a prescription and sells FDA-approved products.
  • If you don't already have a contact lens prescription, obtain a valid prescription and eye exam from an ophthalmologist or optometrist.
  • Even if you have [regular or unimpaired] vision, a [comprehensive] eye exam and prescription are mandatory in order to fit the right size contacts. Do not fall victim to false advertising claims and lenses labeled as "one size fits all" or "no need to see an eye specialist."
  • Follow the directions for cleaning, disinfecting and wearing the lenses. Contacts that are left in for too long or that are not properly cleaned and disinfected can significantly increase the risk of an eye infection.
  • Never share contact lenses with another person or wear expired lenses.
  • If you notice redness, swelling, excessive discharge, pain or discomfort from wearing contact lenses, remove the lenses and seek immediate medical attention. Eye infections like keratitis can become serious quickly and cause blindness if left untreated.

To all of our valued readers: Please have a happy – and safe – Halloween by following these critically important safety guidelines. Enjoy your holiday!

Acknowledgements

Note: Lady Gaga Bad Romance is a screenshot from a copyrighted music video or promotional video for a music artist. The use of a limited number of web-resolution screenshots for identification and critical commentary on the music video qualifies as fair use under United States copyright law.

Note: Circle contact lens and Venus Palermo photos are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.


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