Positive results from a Phase II advanced dry macular degeneration study has opened doors to a Phase III clinical trial involving more than 900 patients in 20 countries. The study will run for two years.
The drug Lampalizumab “slowed progression of dry, aged related macular degeneration in patients with advanced disease, shrinking the area of geographic atrophy (GA) by 20.4%” according to the Phase II MAHALO study results. The principal investigator, Carl Regillo, MD, from the Wills Eye Hospital in Philadelphia, Pennsylvania states, “MAHALO is the first study to demonstrate a positive treatment effect with a complement inhibitor in geographic atrophy.” The main purpose of the Phase III trial will be the same – to see if the drug can promote a change in the GA area. Evaluations to monitor these changes will be by retinal imaging.
Eligibility and Intervention
The drug will be given by intravitreal injection. However, not every participant will be given the drug. The study is a randomized, double-blind, placebo controlled study. This means that some patients will get the drug and others will get a placebo or sham. Neither the participant nor the retinal doctor will know which patients are receiving the drug or the placebo until the end of the study.
Eligible candidates for the Phase III study must be 50 years or older and have evidence of Geographic Atrophy (GA) caused by macular degeneration with no choroidal neovascularization (wet AMD) in both eyes.
Inhibiting the Complement Pathway
Lampalizumab works by inhibiting the complement pathway. Ophthalmologist Phil Rosenfeld of Bascom Palmer Eye Institute in Miami, explains complement activation this way, “The complement pathway is responsible for preventing infection. When the pathway gets activated by bacteria, viruses, and foreign tissue, it destroys the invading organisms and transplanted organs. During the activation process, normal tissue can get damaged. In AMD, it is believed that people with AMD carry mutations in their DNA that cause the complement system to become over-activated and the pathway accidentally destroys normal tissue.
“Lampalizumab has the potential to represent a significant breakthrough for this disease and could provide real hope for GA patients,” said Sandra Horning, Roche’s chief medical officer. “It is the only ophthalmic drug in clinical development that specifically targets complement factor D.”
Leslie Degner, RN, BSN
In a recent blog by ophthalmologist and low vision specialist, Lylas Mogk, MD., she reports that “about 30% of people with vision loss experience Charles Bonnet Syndrome (CBS) for a year or two, in which they see clear, colorful images of people, animals, flowers or buildings, for example, that aren’t really there. The person seeing these is usually aware that the images are not real, as they may be superimposed on their living room wall or appear in the sky.”
Such was the experience of my father-in-law who has wet macular degeneration (AMD). He would see mothers and children in bright color clothes riding bikes on the side of the road while he was in the car or sitting in his yard. At first these visual hallucinations alarmed him and he spoke to his primary care doctor and explained that he was seeing these visions. Unaware of Charles Bonnet Syndrome, she ordered a brain CT scan for him. On the weekend before the test, he told me about his symptoms. When I explained that these strange sightings were not uncommon in those with macular degeneration or other vision loss, he felt great relief. Dr. Mogk goes on to explain, “ It’s important to know that these are not pathological hallucinations; they are just your eyes playing tricks on you, similar to phantom pain, for example, when someone feels like an amputated finger is itching but it can’t be because it’s not there.”
In a recent survey of general practitioners (GPs) by the Macular Society it was reported that 58% of those that responded were aware of the link between macular degeneration and visual hallucination. And an estimated 20% of GPs learned about CBS from their patients. Such was the case with my father-in-law. I instructed him to have a conversation with his GP about CBS and his symptoms before he had the CT scan in case she wanted to cancel the test.
Thankfully my father-in-law told his doctor about his “sightings” and found great relief knowing that his hallucinations were not from some other serious disorder. However, that’s not the case for many other patients who suffer in silence afraid of what these abnormal visions might mean.
Dr Waqaar Shah, of the Royal College of General Practitioners and the UK Vision Strategy Eye Health Clinical Priority Project, commented, “Patients will rarely volunteer this symptom for fear of being judged as having a mental health condition so it is important GPs raise awareness amongst patients so that they can receive appropriate support. “
Learn more about this syndrome so that you can discuss it with someone you know with vision loss or maybe even your GP:
Charles Bonnet Syndrome
Leslie Degner, RN, BSN
There has been lots of activity in the research world using embryonic and adult stem cells to treat not only macular degeneration, but other eye diseases as well, such as Stargardts macular dystrophy, optic nerve disease and glaucoma. These early Phase I clinical trials enroll very small numbers of patients, leaving the rest of the world to watch and wait.
But perhaps there are other ways to replace damaged cells with healthy stem cells produced by your own body. Damon P. Miller II, M.D. board-certified medical doctor, fellowship-trained radiologist and certified by the American Naturopathic Certification, has written a book called Stem Cells Heal Your Eyes: Prevent and Help: Macular Degeneration, Retinitis Pigmentosa, Stargardt, Retinal Dystrophy, and Retinopathy. Dr. Miller does not practice traditional medicine but rather uses natural, drugless therapies to treat chronic medical conditions. He has devoted a significant part of his practice to the treatment of eye disorders.
Dr. Miller worked with Grace Halloran, PhD to put together several eye health therapies now called the Better Eye Health Program, that seek to prevent vision loss from eye diseases such as retinitis pigmentosa (RP) and macular degeneration. Dr. Halloran was diagnosed with RP and macular degeneration at the age of 25. When her son was born he also inherited the defective gene for RP. After many visits to academic medical centers she received the same answer from all of them – there is nothing we can do for your son’s vision. Not to be deterred she determined that she must take responsibility to find or pave her own way to prevent this eye disease from taking her and her son’s vision. She was able to restore much of her own vision and her son’s vision remained healthy and normal through a variety of different therapies along with diet and nutrition. Dr. Miller writes, “Dr. Halloran’s therapies were helping people support their own adult stem cells to regenerate damaged eye tissue.” You can read Grace’s story in her autobiography, Amazing Grace, Autobiography of a Survivor.
Unlike a single injection into the eye, the stimulation of one’s own stem cell production involves many different therapies and approaches. Also unlike today’s healthcare which treats a single part of the body, such as the eye or the retina, these therapies work to improve systems of the body such as increasing circulation, providing nourishment and oxygen, and reducing chronic inflammation. According to Dr. Miller, “when an individual incorporates certain disciplines into their lifestyle, vision can be improved and degeneration can be slowed or stopped.” Here are some of the therapies he uses:
Dr. Miller explains, “Adult stem cells allow the body to repair damaged tissue previously thought irreparable including eye tissue.” Find out more about his book and the Better Eye Health Program here:
Leslie Degner, RN, BSN
Ocata Therapeutics, formerly known as Advanced Cell Technology, is conducting a study for the treatment of dry macular degeneration (AMD) at several sites in the United States. The company concentrates their efforts in a new field of treatment, called regenerative medicine. “At the very core of our regenerative ophthalmology efforts is the notion that we can change the course of degenerative eye disease by identifying which cell types are compromised or lost due to disease, and replacing those missing cells with the same cell generated from a stem cell source.” Instead of treating symptoms their goal is to rejuvenate, replace and even regenerate damaged retinal tissue.
One of their current studies is for the treatment of dry AMD. It is a Phase I/II study “to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (MA09-hRPE) Cells in Patients With Advanced Dry AMD.” Patients receive the stem cells via a single injection into the eye. There will be 5 cohorts or groups of patients – each group receiving a different amount of MA09-hRPE cells transplanted
Three AMD patients will receive 50,000 MA09-hRPE cells transplanted
Three AMD patients will receive 100,000 MA09-hRPE cells transplanted
Four Better Vision AMD patients will receive 100,000 MA09-hRPE cells transplanted
Three AMD patients will receive 150,000 MA09-hRPE cells transplanted
Three AMD patients will receive 200,000 MA09-hRPE cells transplanted
The first group of patients will be followed for 6 weeks and evaluated by an independent Data Safety and Monitoring Board before proceeding with the next group of patients. Patients will remain in the study for 12 months.
At the time of this writing, February 2015, they are recruiting a small number of participants. This is a partial list of the criteria one must meet to be eligible.
Male or Female adults 55 years or older
Be in reasonably good health with the expectation of living at least 4 years after treatment
Diagnosed with advanced dry AMD
Have clinical signs of Geographic Atrophy
Cannot have wet AMD in the treated eye
Jules Stein Eye Institute, UCLA School of Medicine in Los Angeles, CA
Bascom Palmer Eye Institute in Miami, FL
Wills Eye Institute in Philadelphia, PA
Mass Eye and Ear in Boston, MA
The injected cells used in this clinical trial are the same cells they are intended to replace. Once injected, they will seek out the areas of degeneration and according to Ocata, “replace the missing native cells and regenerative the structure of the eye and restore its function.” Study results when published will report on the safety of the procedure, the success of the engraftments, and any vision changes. For more detailed info on this type of research visit:
Leslie Degner, RN, BSN
The iolAMD is a breakthrough in the treatment of macular degeneration. Patients are reporting that once the new lenses are implanted they are able to see faces, enjoy colors, drive and read again. These telescopic lenses work differently than other macular degeneration implants in several ways. It is available to a wider range of patients with vision problems, there is no need for low vision rehab after they are implanted, and the procedure is less invasive, without even any need for stitches.
Unlike other macular degeneration implants that are just for those with advanced AMD, the iolAMD can, according to the iolAMD website, “help patients with early, intermediate and end stage dry AMD and established wet forms of AMD. iolAMD can also help patients with other forms of macular disease including diabetic maculopathy, macular holes, myopic degeneration, diabetic retinopathy and hereditary retinal diseases such as Stargardt’s and Best’s.”
Patients are first seen in a doctor’s office with a simulation test to determine whether or not they would benefit from the implants. If there is vision improvement with the office test, it is highly likely that the lenses would also offer improved vision.
Two tiny lenses are implanted through a minimally invasive procedure, using a micro-incision – much like a cataract operation – but even less invasive. The incision is only 3 mm compared to 8-11 mm for other implants. Because the incision is so small, no stitches or sutures are needed. The procedure is done in 5” to 10” under a local anaesthetic. The smaller incision means quicker healing and less surgical risk. The natural lens is removed and two iolAMD lenses are actually “injected” into the eye. Unlike other telescopic lens implants, each eye receives a lens. The two lenses actually work together in two ways:
It takes about 1-2 months for the eyes and brain to adjust to the new way of seeing. These optic lenses were developed by eye surgeon Dr Bobby Qureshi and optical physicist Professor Pablo Artal. The unique characteristics of the lenses means there is little to no distortion and significant improved vision.
Where Is It Available
As of this writing the lenses are available in the United Kingdom, France, Italy and Germany. The U.S. is still waiting for FDA approval. To watch a video on how these optic lenses work visit:
Leslie Degner, RN, BSN
Vitamin D is a fat-soluble vitamin that benefits our bones, our mental health, our immune system, our heart health and yes, even our eyes. Vitamin D deficiency is more common in patients with wet macular degeneration than in those with dry age related AMD according to the September 2014 issue of the medical journal Retina. The research found that the vitamin D levels were lower and more prevalent in those with neovascular (wet) AMD. It may be due to the effects of vitamin D preventing angiogenesis – or new blood vessel formation. It also provides the benefit of being anti-inflammatory. Inflammation plays a key role in the development of AMD.
According to Michael Holick, Ph. D., M.D., the author of The Vitamin D Solution, those with wet AMD are not the only ones deficient in this vital nutrient. “The vitamin D deficiency and insufficiency that afflict at least half of the worlds population, and remain one of the most undiagnosed medical conditions, are real – and very serious.” He goes on to say that “Three out of every four Americans are deficient in vitamin D, up from one out of two twenty years ago.”
Health Consequences of Vitamin D Deficiency
Sarfraz Zaidi, M.D., the author of the Power of Vitamin D states that there is a relationship between vitamin D deficiency and bone pain, osteoporosis, immune disorders, heart disease, high blood pressure, depression and cancer.
Ask your doctor to do a 25-vitamin D test. It is a simple blood test that is sent off to the lab. Dr. Holick recommends levels to be in the range of 30 to 100 nanograms per milliliter of blood.
How to Increase Your Levels
You can increase your vitamin D levels in three ways.
Laura Jeffers, a registered dietitian at Cleveland Clinic salmon. “Salmon is a great source of Vitamin D and having 3 ounces, a couple of times per week, will help support your Vitamin D intake,” she said. Wild caught salmon has higher amounts of this vitamin than does farm raised. However, Dr. Holick informs his readers that “you can’t rely on diet to obtain it.”
Dr. Holick states, “I typically recommend taking 1,000 to 2,000 IU of vitamin D a day – that should be adequate along with a multi-vitamin that contains 400 IU of vitamin D.
3. Sun Exposure
Vitamin production is triggered when skin is exposed to ultraviolet light. Dr Holick’s preferred method is that sunlight be most people’s main source of vitamin D. Find out how to safely expose your skin to enhance your vitamin D production here:
Leslie Degner, RN, BSN
As someone who eats very healthy, including lots of fresh salads and vegetables, I discovered that all this good food could be better utilized with a healthy digestive system. Dr. Steven Lamm, MD, internist and faculty member at New York University School of Medicine, writes, “When the digestive system is working properly it serves as a barrier to bacteria, viruses and pathogens of all kinds.”
Diminishing Digestive Enzymes
There are some things we can do and other things we can’t avoid that adversely affect the production of pancreatic enzymes. They are:
1. Aging Children and young adults normally have good digestive health, but Dr. Susan Lark the author of Enzymes the Missing Link to Health, writes that “by the time most people reach their forties and fifties, the biochemical aging of the body begins to accelerate and the production of digestive enzymes diminishes. “ Some doctors suggests that by age 50 you may be making half the amount you did when you were younger.
2. Standard American diet Lack of fresh vegetables and fruits means a lower supply of digestive enzymes. Raw fruits and vegetables provide needed enzymes to digest our food. Once cooked, the enzymes are destroyed.
4. Alcohol overuse
Why You May Need Digestive Enzymes
1. Digestive enzyme production diminishes with age
2. Digestive processes become less efficient with age
3. Reduced motility – the ability of food to move through the digestive tract – occurs with aging
4. Stomach produces less hydrochloric acid with age which helps with protein digestion
Signs of Digestive Enzymes Deficiency
As people age they may find that foods they once enjoyed, they can no longer tolerate. Some digestive symptoms listed below may be a sign that you are deficient in your enzyme production:
How to Improve Your Digestive Health?
1. Take digestive enzymes to improve your health and immune system
2. Take these supplement just before a meal
3. Chew your food to increase your own natural production of enzymes
4. Eat raw foods such as pineapple, mango, kiwi, and papaya
Heated foods destroy enzymes while raw and organic foods contain the most enzymes.
A diet that includes enzyme rich foods and digestive enzyme supplements can help to support physical and mental energy by improving the absorption and assimilation of nutrients. Dr. Susan Lark ties the role of digestive enzymes with the inflammatory process. “The production of abundant pancreatic enzymes not only helps to hasten recovery from trauma, respiratory illnesses and exertion, but can be useful in the treatment of a number of inflammatory diseases ….”
Leslie Degner, RN, BSN
You may be wondering why I would write an article about digestion, when my readers here are concerned about their eyes and their vision? If there has been one direction in the healthcare field that has been detrimental to our health, it is the treatment of the body in isolation or treating a body part or system as a single entity with no connection to the rest of the body. I’ve seen it so many times in my work as a registered nurse and in the lives of my own family members. As an example, a family member developed a stress fracture in the pelvic area – an unusual place for one so young. She was a long distance runner and the specialists simply concluded it was from running. However the MRI showed osteopenia. When doing our own research we found that those with gluten intolerance or with gluten allergies often develop osteopenia. Indeed the relative was soon diagnosed with this food allergy and has since been able to restore her bone health. Even though she ate mostly organic and unprocessed foods, the gluten allergy interfered with her ability to absorb and utilize many essential nutrients.
Connection Between Immune Health and a Healthy Gut
“As a result of understanding the critical connection between the gut and immunity I’m fully convinced that nobody can achieve optimum health without focusing on the health of their gut. A simple approach to maintaining a healthy gut is the use of supplemental enzymes.”
Steven Lamm, MD, practicing internist, faculty member at New York University School of Medicine
Perhaps like me you eat a healthy diet filled with lots of nutrient rich vegetables and fruit, even organic ones. On top of that you take vitamins and supplements. But what if your body is not utilizing or absorbing those nutrients, vitamins and minerals as well as it could? That is a recent concern I had when I came across the book Enzymes: The Missing Link to Health by Dr. Susan Lark. She first explains the importance and significance of digestive enzymes by explaining what they do. Digestive enzymes:
1. Break down foods, like carbohydrates, fats and proteins. Without enzymes, food would just sit in the gut without being of any benefit to the body
2. Facilitate the absorption of nutrients into the cells
3. Help to eliminate toxins
4. Prevent bacterial and fungal overgrowth of the small intestine
5. Boost our immune system
6. Reduce inflammation.
Macular degeneration is one of many diseases that is linked to an inflammatory process. Anything we can do to reduce chronic inflammation helps to maintain or support our health. Dr. Lark writes, “The inflammatory process is controlled by numerous digestive enzymes, especially the body’s own pancreatic protein-digesting enzymes …”
Find out more about this important element to help support your health here:
Leslie Degner, RN, BSN
“Inflammation is the underlying factor of virtually all diseases encountered in the twenty-first century “ states ophthalmologist and author of the SuperHealth books Stephen Pratt.
There are two kinds of inflammation – acute inflammation and chronic inflammation. Acute inflammation is when we experience something like a sprained ankle. It becomes painful, swollen and red. The body responds in many different ways to bring healing to the ankle. Chronic inflammation is less evident but no less harmful. Systemic or body-wide inflammation affects our health at the cellular level. Dr Damon Miller, author of Stem Cells Heal Your Eyes, describes it this way, “inflammation results in abnormal electrical activity …areas with abnormal electrical activity have decreased cellular and mitochondrial performance. This in turn leads to oxidative damage to tissue.” Not only does system wide inflammation lead to degenerative eye diseases like macular degeneration and cataracts it is the precursor to most diseases like cancer, heart disease, Alzheimer’s and diabetes. The good news is that we can improve our health at the cellular level by decreasing pro-inflammatory responses and increasing our anti-inflammatory activities.
What Promotes Chronic Inflammation?
Lifestyle choices like smoking, chronic sleep deprivation, lack of exercise, stress and being overweight contribute to this cellular breakdown. Most of today’s processed foods that include bad fats and sugar are pro-inflammatory as are refined grains and grain fed meat. “Our environment of toxins, with bad fats and too much sugar, is like pouring gasoline in a fire lit in a hearth – pretty soon it gets out of control and burns the whole house down. That’s what’s happening to our bodies ….” states Steven Pratt, MD in his book SuperHealth: 6 Simple Steps, 6 Easy Weeks, 1 Longer, Healthier Life.
What Reduces Chronic Inflammation?
Include exercise and adequate sleep for better health. Reduce stress in your life and be sure to drink plenty of filtered water to “put out the burning embers” of inflammation. Choose healthy fats like olive oil and fresh avocados for your salads. Cook with coconut oil. Use it to saute vegetables or for baking. Wild caught salmon is considered one of the top anti-inflammatory foods as are fresh fruits and vegetables which are rich in antioxidants. Spices like turmeric and ginger fight inflammation. Nuts like walnuts, cashews and almonds are sources of healthy fats as long as they are eaten raw.
The health benefits of an anti-inflammatory diet are not just for your eyes. It fights aging and degenerative diseases. Discover the key things you can do to reduce inflammation through healthy food choices: Anti-Inflammatory Diet
Leslie Degner, RN, BSN
Are you concerned that you may inherit an eye disease from one of your parents or that you have handed down your eye condition to your children? Thanks to the field of nutrigenomics, our inherited genes are just part of the story. In 2003 the Human Genome Project was completed that provided a detailed map of human DNA. Many researchers and scientists have discovered the genetic flaws that lead to many different eye diseases – such as retinitis pigmentosa, Stargardt’s disease and macular degeneration. For instance genetic changes involving the CFH gene contributes to a person’s risk of developing age-related macular degeneration and mutations in the ABCA4 gene lead to Stargardt’s disease. However your genes alone may not determine your destiny. You may be able to suppress harmful genes through diet and lifestyle and express your healthy genes in the same way.
“The exciting, emerging field of nutrigenomics is introducing us to new ways to use food and lifestyle choices to suppress our “bad” genes and express the “good” ones that help prevent disease, counter environmental toxins and increase longevity factors.”
Stephen Pratt, MD and Ophthalmologist Scripps Health
It is not just having defective genes that predispose us to certain diseases, it is the expression of the gene that leads to poor health. Genes can be turned on or turned off. Nutrition and lifestyle choices affect how genes function or how they are expressed. Normally it is not just one gene that leads to a chronic disease, but a number of different genes. Unlike the medical field that focuses on treating diseases once a patient has been diagnosed, nutrigenomics works by intervening before a person develops a chronic condition.
Turning Off the Bad Genes and Turning On the Good Genes
Foods and/or supplements can influence how your genes work. Suppressing the expression of harmful genes may delay or even prevent some of these eye diseases. According to the Center of Excellence for Nutritional Genomics at the University of California, Davis,
“Nutrigenomics has received much attention recently because of its potential for preventing, mitigating, or treating chronic disease, and certain cancers, through small but highly informative dietary changes. “ While good nutrition can turn on the good genes, poor nutrition can turn on the expression of bad genes. It is just as important to exclude unhealthy foods as it is to include healthy foods.
Researchers are finding that certain foods can access our cells DNA to signal a good gene to turn on. It is the bioactive chemicals in food or supplements that can alter the structure or expression of our genes. Nutrigenomics is still a very young field of science but it is offering hope to those who believe that they are defined by their inherited genes.
Leslie Degner, RN, BSN