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As promised in April, Ohr Pharmaceutical, Inc. has provided interim results for the Phase II clinical trial of Squalamine eye drops in patients with wet age-related macular degeneration (wet AMD). This study compared the use of Squalamine eye drops in combination with Lucentis treatment versus a placebo eye drop and Lucentis treatment. The visual acuity improvements were seen as early as four weeks and the relative difference in visual acuity between the two treatment arms continued to increase throughout the study. The data is from the first 62 patients (29 treated in the Squalamine arm, 33 treated in the placebo arm), who completed the entire nine months of the treatment protocol (representing approximately 50 percent of the targeted study population). The Squalamine-treated group demonstrated improved vision to a greater degree than the Lucentis only group. Over 48 percent of Squalamine-treated patients showed improvement of more than three lines on the standard eye chart, versus 21.2 percent in the placebo group. In addition, patients receiving Squalamine drops were more than twice as likely to gain more than 4 or 5 lines of vision compared with patients in the placebo eye drop group.
Two-year clinical trial data was just released for epimacular brachytherapy, a radiation treatment for wet AMD. The MERITAGE trial involves 53 patients who had previously been treated with Lucentis and who had required monthly injections to control blood vessel growth. Individuals in the study received a single treatment with epimacular brachytherapy, a unique radiation delivery system . Over three years, the participants are then treated as needed with Lucentis. Sponsored by NeoVista, the study looks at safety, gain or loss of vision, and number of Lucentis injections needed. A lot of research is being focused on reducing the burden of monthly injections for those with wet macular degeneration.
Recently, the news was full of headlines about blood pressure medication that may be associated with an increased risk for early development of age-related macular degeneration. As is often the case with bold headlines, the rest of the story is more complicated. The data was from the Beaver Dam Eye Study, a long term population study from Beaver Dam, Wisconsin, involving almost 5,000 people over a 20 year period. Of these, 1913 are still in the study. It may be important to note that 99% of the participants are white.
High cholesterol is often cited as a contributing factor to age-related macular degeneration. Many studies have shown an association between AMD and serum lipids. People with high cholesterol often take statin medication to reduce the cholesterol level. Some studies have even shown an association between statin drugs and a reduction in the occurrence of AMD. The evidence is confusing. A soon to be published review doesn’t clarify the picture, unfortunately. They looked at all the data from three large population studies for AMD (Beaver Dam Eye Study, Blue Mountains Eye Study, Rotterdam Study). Combined, they involved almost 7000 people.
Oxford BioMedica announced that it has completed enrollment of the Phase I RetinoStatR clinical trial for wet macular degeneration. Results are expected towards the end of 2014.
The use of drugs to stop the growth of blood vessels in macular degeneration (Lucentis, Eylea, Avastin, Macugen) revolutionized treatment for wet AMD.
We tend to take eyedrops for granted; most of us have used them for a variety of problems. We drop them on the surface of the eye (the cornea) and they help soothe dry eyes, for instance. But what if they could somehow reach all the way to the back of the eye, to the retina where macular degeneration is destroying vision? Historically, drugs in eye drops couldn’t cross that barrier, but nanoparticles are extremely small and may make it possible.
Our Pharmaceuticals announced they have completed enrollment in their Phase II clinical trial of Squalamine eye drops. There are now 142 patients in the study. The drug is designed for wet age-related macular degeneration (AMD). In June of this year, they plan to release the interim results from the first 60 patients.
Several research programs are looking at various types of radiation treatment for wet macular degeneration. Recently, one form, brachyotherapy, showed disappointing results.
But, at the Academy of Ophthalmology meeting, another treatment was more encouraging. Dr. Darius M. Moshfeghi, from Standord University, reported on a technique called Radiotherapy. It does seem to reduce the number of injections needed in people with wet AMD, which was the goal of treatment.
Are macular degeneration and Alzheimer’s disease linked in some way? In recent years, some have said yes, pointing to the presence of plaque in both diseases. In Alzheimer’s, there is plaque on the brain; in AMD, it takes the form of protein deposits (drusen) in the retina. And certainly, people with Alzheimer’s do get age-related macular degeneration. But, more recent research does not see them connected.
According to Jeffrey S. Heier, MD, the eye is the ideal location to try gene therapy because it is such a small organ. Two Phase I clinical trials are underway to study the safety and dosages of different gene therapies for wet AMD. In gene therapy, a virus vector (a sort of transport vehicle) carries the therapy to the retina. A piece of DNA is spliced into an engineered virus. The benefit is that it can persist indefinitely; it would be a one time treatment.The technique has been successfully used to treat Leber congenital amaurosis type 2 (a retinal disease that affects children),so there is some hope it might be used successfully for macular degeneration.
One of the most interesting potentials for genetic testing is to determine if a patient’s genes will affect how well a treatment works. This could include how well vitamin supplementation for AMD works. There is some evidence that certain patients respond better to the AREDS formula. On the other hand, routine genetic testing is not recommended. Two researchers discussed this issue.
If you missed our September report, this is an update to the MAHALO Phase II results reported at the recent Academy of Ophthalmology meeting by Dr. Carl D. Regillo, Director of the Retina program at Wills Eye Institute in Philadelphia.
The MAHALO clinical trial of “lampalizumab” showed some exciting progress for dry macular degeneration. The advanced form of dry AMD is called geographic atrophy (GA), in which a whole patch of cells degenerate and stop working. The larger the patch, the worse the vision – and the patch tends to get bigger as things progress.
“Photoreceptor cell death is the ultimate cause of vision loss in many eye diseases, including AMD.”, according to Dr. Joan W. Miller, from Harvard Medical School and the Massachusetts Eye and Ear Infirmary. The photoreceptors are the light sensitive cells that are the first layer of the human retina. They are the “rods”, which give us black and white vision and the “cones”, which provide color vision.
There are several causes of cell death in diseases like AMD and more than one may be active at the same time.
The majority of current treatments for wet AMD (Lucentis, Avastin, Eylea, Macugen) stop the growth of blood vessels by acting again VEGF, the growth factor that prompts the blood vessel growth. They require repeated injections into the eye, sometimes once a month and are expensive. Doctors and patients alike would prefer an AMD therapy that is less invasive.
A clinical trial is underway to study whether the use of eye drops could maintain or improve vision, while reducing the number of injections. The objective was, 1. to show that the eye drops were “noninferior” to Lucentis (i.e., they did at least as good a job) and 2. to reduce the number of injections by 50%.
Pazopanib is a small molecule that acts against not only multiple VEGF signals, but also against another growth factor, called PDGF. The eye drops were administered daily by the patients themselves. Treatment with Lucentis was given monthly to one group and as needed to the rest of the participants. There were different dosages used and one group of patients received a sham treatment (eye drops without any medication in them).
Since the FDA approval of Lucentis – and the off-label use of Avastin – there has been an ongoing debate about which treatment is best. At every Retina meeting for years, the pros and cons have been presented and this year is no different, though several speakers felt it had been resolved for once and for all. Dr. Daniel F. Martin, who headed the NEI’s comparison study (CATT), stated, “Very few of the differences between these drugs, whether they favor Lucentis or Avastin, are clinically significant. I think we’re done with this question.”
Several clinical trials were reported that showed Lucentis and Avastin to be essentially the same in effectiveness and safety. But physicians continue to use both treatments, as some patients respond better to one or the other – and switching treatment from one to the other can sometimes be more effective at some point.
The STEM clinical trial has just treated the first high-dose patient in their Phase I/II clinical trial for dry macular degeneration. One million HuCNS-SC cells were injected beneath the retina. Patients treated earlier in the trial only received 200,000 cells. A review of the safety data found no issues, so the researchers were approved to use the higher dose.
There are a total of 16 patients in the trial and the remaining subjects will all receive the one million cell dose. The company is also expanding the number of trial sites. They hope both of these actions, approved by the FDA, will move the research forward more quickly.
A few months ago, the U.S. Food and Drug Administration approved the use of the Argus II retinal implant in those with retinitis pigmentosa (RP). This month, Medicare issued a billing code, clearing the way for payment.The Argus II has been under development for years, with hope that it could provide an “artificial retina” and return vision to those who are blind. People with retinitis pigmentosa (RP) lose portions of their vision over a span of years, eventually becoming completely blind. Since those who have age-related macular degeneration always retain some peripheral vision, the Argus II is not an option at this time.
We know that fruits and vegetables contribute to eye health. Many of us are trying to get at least 5 servings a day to hold off vision loss. Past research indicates that people who eat more vegetables lower their risk of macular degeneration.Here’s another reason to load up on those antioxidants. A large study in Sweden showed that eating five servings a day of fruits and vegetables increases lifespan by nearly three years.
People with age-related macular degeneration (AMD) are encouraged to eat a diet high in fruits and vegetables, especially dark green leafy vegetables. Long term studies have shown that those who do eat their antioxidants have a lower risk of developing AMD.Now there is research showing that veggies can maintain your mental capacity for longer.
Stem cell therapy for AMD is being watched by patients and physicians alike. The early clinical trial data is encouraging and hopeful, but we’re a long way from anything available to the average patient. Because research is frustratingly slow and patients who are losing sight can become desperate, individuals may be tempted to go outside their home country for unproven treatments.Stem cell therapy for AMD is not ready outside of clinical trials. Yet there are countries where you can obtain it now. A consortium of leading organization working on stem cell treatments has issued an advisory to those considering such travel. Their announcement is provided below.
The MAHALO clinical trial of “lampalizumab” showed some exciting progress for dry macular degeneration. The advanced form of dry AMD is called geographic atrophy (GA), in which a whole patch of cells degenerate and stop working. The larger the patch, the worse the vision – and the patch tends to get bigger as things progress. This new drug was shown to reduce the size of the GA by 20% after 18 months. In a certain subgroup of patients, the rate of progression was decreased by 44% in that same time.
The Phase III clinical trial of epimacular brachytherapy found it to be inferior to monthly injections with Lucentis. Earlier results were promising. There was hope that a single dose of radiation could mean patients would get fewer injections for wet macular degeneration.The CABERNET study involved 227 patients who had the radiation treatment and two monthly injections of Lucentis. After that, they were treated with Lucentis as needed. A control group received Lucentis only on the standard treatment intervals.
Japan has just announced the start of a clinical trial for the use of “induced pluripotent” (iPP) stem cells for macular degeneration. Stem cells can develop into any part of the body and earlier clinical trials are using embryonic stem cells. iPP, as they are called, are cells from the adult patient. In this case, the patient’s skin cells will be harvested and reverted back to stem cells. These will be used to grow retinal cells, which will then be transplanted into the patient’s eye.
The development of a pill for macular degeneration has been watched closely for a number of years. Early studies in healthy subjects showed the pill to be safe. At the recent ARVO (Association for Research in Vision and Ophthalmology) meeting, the results of a study with AMD patients was announced. The intent of the study was to confirm the safety of various doses of the pill and to identify the way the pill worked.
Mid-summer farmers’ markets and roadside stands serve up fresh, newly picked veggie nutrition. It’s not all about the dark leafy ones, either. Here are some tips from our partners at EyeFoods about what to eat for macular degeneration.Green vegetables are a great source of vitamins and antioxidants that promote overall health, however, these four are the all stars for eye health. With a bit of creativity, these gems can be turned into a multitude of different dishes.
- Contains lutein and zeaxanthin, vitamin C, vitamin E, beta carotene, fiber
- Make a stir-fry with broccoli and lean beef. Add low sodium soy sauce, garlic and pepper. Serve over a healthy whole grain such as quinoa or barley.
- Cut out broccoli florets. Peel the stem and shred it. Mix with you favorite vinaigrette for a new twist on coleslaw – broccoli slaw
- Mix small broccoli florets with a little olive oil and sea salt. Roast broccoli in oven until it starts to brown, about 15 minutes at 375. Enjoy.
- Contain lutein and zeaxanthin, beta-carotene, fiber
- Children love them half-thawed as a pre dinner snack
- Add to stir-fries and soups.
- Add steamed peas and edamame to a bowl of rice, with sautéed chicken or tofu. Great in a thermos for lunch the next day.
- Contain lutein and zeaxanthin, vitamin C, beta carotene, fiber
- Roast Brussels sprouts in the oven to bring out their sweet, complex flavour
- Use Brussels sprouts instead of cabbage in a soup for added nutritional value
- Contain lutein and zeaxanthin, beta-carotene and fiber
- Mix steamed green beans with ½ can of light tuna and baby spinach for a quick lunch salad.
- Steam green beans until tender-crisp. Immediately shock in ice water to keep the color and stop cooking. Keep in the fridge and add to salads, soups, pasta dishes and stri-frys
- Steamed green beans with sea salt and olive oil, garnished with slivered almonds are a classic side dish.
For more information on Eyefoods, click here.
We can always tell when a story about AMD hits the news because there is a jump in phone calls and emails. Recently, it was a story about a new contact lens for macular degeneration.Researchers at the University of California, San Diego have developed a prototype for telescopic contact lenses, but it needs a great deal of research before it is ready.
The National Eye Institute released the five-year results of AREDS 2 this week, at ARVO, the annual meeting of the Association for Research in Vision and Ophthalmology. This follow-up to the Age-Related Eye Disease Study (AREDS) looked at changing the formula for the AREDS supplement. Specifically, they studied the effect of adding lutein, zeaxanthin and omega-3 to the original formula. The results showed that lutein and zeaxanthin may be helpful, but omega-3 did not have a positive effect over five years.
Peggy Wolfe offers an invaluable and inspirational road map to living with AMDWhen her ballet class surprised her with a birthday party two years ago, Peggy Wolfe danced across the floor, shouting, “Eighty Power! Eighty Power!” It was a fitting entry into octogenarianism for the diminutive powerhouse.
During the 1950s, Wolfe and her soon-to-be husband visited her blind uncle in St. Paul, Minnesota, on Wednesdays. They took turns reading to him from his beloved books about the Civil War. Uncle Matt was an inspiration to Wolfe, as she watched him sit at her family’s dining-room table, poring over large sheets written in braille, knowing he had taken two streetcars, with the help of his white cane, to get there.
How often have you heard, “Eat more fruits and vegetables, especially dark green leafy ones”?Most people think spinach first and stop there. But, there are many fresh greens available now besides spinach and some of them have more lutein than spinach.
In honor of National Nutrition Month, here is a healthy vegetable soup recipe from one of our partners.A few months ago, we did a presentation on AMD in Highland Park, California at a senior living community. It was sponsored by WORKS and they provided a delicious dinner for the attendees. Everyone loved this warm and healthy winter meal.
Thanks to Marlene Aguilar for her great recipe. You can adjust the amounts and add other healthy veggies to the mix as you wish. Reduce the potatoes if you’d like to lower the calories. Freeze any leftovers for an easy dinner or lunch later in the month.
Retina Implant AG has just published the results from part of a multicenter clinical trial of their artificial retina implant. According to the company, “…during the course of a three to nine month observation period, functional vision was restored in the majority of nine German patients implanted with a subretinal microchip as part of the first module of the Company’s second human clinical trial.” These individuals all have retinitis pigmentosa (RP) and severe vision loss. The vision achieved by the patients exceeded the results from the first clinical trial. MDP has been following this story for a number of years and each report is more encouraging than the previous one.
The U.S. Food and Drug Administration (FDA) has approved the first artificial retina, or bionic eye. The Argus II system was approved on February 14, 2013, for use in retinitis pigmentosa (RP). RP affects about 100,000 people in the U.S., but only about 4,000 of them would be eligible for the device. At this time, it is not approved for age-related macular degeneration (AMD), although further development of the system could make it useful for AMD.
Michael Gorin, MD, PhD at Jules Stein Eye Institute at UCLA is looking for individuals age 49-65 years old, who have at least one parent with macular degeneration. He is conducting a nationwide study of genetic and other risk factors that contribute to the development of age-related macular degeneration. You or members of your family may be eligible to participate – and you don’t have to travel at all!
For a large portion of my life, I lived in blissful ignorance of the devastating disease known as age-related macular degeneration. In fact, I only became familiar with the term ‘macular degeneration’ when my grandfather was first diagnosed with the condition about seven years ago.With a smile that can still light up a room and eyes like sapphires, my grandfather is a vibrant octogenarian who proudly fought in World War ll, beat cancer and is now learning to live with age-related macular degeneration.
The implantable miniature telescope (IMT) was approved by the FDA in 2010 for advanced macular degeneration. It has not been available in many places, but VisionCare Ophthalmic Technologies, Inc. has just announced a list of 30 locations in the United States where the IMT will be available.
Good lighting can make a big difference, especially if you are performing a task like reading or paying bills. It also creates a safer environment and helps to prevent accidents. As you age, the amount of light entering the eye is reduced, causing a reduction in vision, contrast and color. The type of lighting and its intensity, color and direction all affect an individual’s visual performance.
There are so many “eye vitamins” available that it gets confusing. I always tell patients that what we DON’T know about vitamin supplementation is far greater than what we DO know. But that is changing every year, thanks to ongoing investigations. The Age-Related Eye Disease Study (AREDS) at the National Eye Institute(NEI), looked at the effect of supplementation with antioxidants and zinc on cataracts and macular degeneration. That research did not find any connection between cataracts and the supplement. But, it did show that the supplement slowed the progression of the disease by 25% in people with intermediate macular degeneration. It also slowed the vision loss by 19% in the same group of people. Since that study, vision scientists have learned more about nutrition and the retina, which prompted the NEI to conduct an AREDS 2 study that used this new information. Here’s a little history.
We know it’s important to eat a healthy diet. But, it’s easy to get lost in the forest of broccoli and waves of grain. How are you supposed to figure out what you need to eat to keep your eyes healthy? How much? How often? It’s all so confusing.
Drs. Laurie Capogna and Barbara Pelletier have written “Eyefoods: A Food Plan for Healthy Eyes” to help you out. Their no-nonsense book contains specific recommendations, recipes and information on eye diseases – and is written in large print.
We’ve all heard about a healthy diet and usually think in terms of eating vegetables and fruits and lowering saturated fats. But, there seems to be another dietary area that needs to be addressed. Eating low glycemic foods may slow the development and progression of AMD.
A recent research study shows that zeaxanthin supplementation may be as effective as lutein in affecting vision. Researchers at the Veterans Hospital in North Chicago, Illinois, conducted a clinical trial of 60 older patients with mild to moderate macular degeneration. Patients in one group received zeaxanthin, another group received zeaxanthin and lutein and the third group received lutein only. 8 mg of zeaxanthin and 9 mg of lutein were used. Patients were tested for vision and visual fields.
A recent research study is getting a lot of attention because it showed a statistical link between daily aspirin use and wet macular degeneration. As usual with these news stories, it’s important to look deeper than the headline. One irresponsible headline actually stated, “Aspirin Causes Blindness” – which is definitely untrue.
Remember that many seniors take a daily aspirin for their circulation and heart health – often prescribed by their cardiologists or other doctors. For this purpose, aspirin is taken because it is a blood thinner.
New Technology Reading Lamps
As the aging eye becomes more opaque, less light reaches the retina. Reading can be easier by the aid of a good reading light.
Since sunlight is a factor in macular degeneration, lamps that mimic sunlight can have a negative effect on the eye. A significant factor is the spectrum – the different colors that make up the light. The colors of the visible spectrum are the colors of the rainbow: red, orange, yellow, green, blue, indigo, and violet. The low energy red through the moderate energy violet are not harmful and are necessary for vision. However, high energy ultra-violet light, mostly UV-B, is responsible for damage to materials, skin, and eyes. Eliminating UV-B from man made light sources is desirable and very prudent for lighting used by individuals over 40. With new technology such as LED (Light Emitting Diode) light sources, it is possible to make a lamp that is tailored to people with macular degeneration. LEDs designed for reading lights have no UV and extremely low IR (Infra Red) emissions. They are very energy efficient without hot lamp surfaces or hot bulbs. The LEDs are long lasting – about 14 years at 8 hours usage per day.
For some time, fish, fish oil and omega-3 fatty acids have been the subject of much research. High concentrations of omega-3s have been found in the eye’s retina. In large demographic studies, people who reported eating fish three times a week had less AMD than those who ate fish less often. A diet rich in omega-3 probably protects against advanced AMD, according the the Age- Related Eye Disease Study (AREDS) at the National Eye Institute. This is the same study that resulted in the AREDS vitamin supplements like PreserVision and I-Caps.
Newly published research from Johns Hopkins School of Medicine supports this finding.
By: Bill Takeshita, OD
Prescription filters are one of the most important visual aids that people with macular degeneration will benefit from wearing. The ultra-violet radiation and blue wavelengths of light can potentially damage the cells of the retina and too much light can actually reduce a person’s ability to see, especially under very bright sunlight.
This issue is a particularly sensitive one for seniors who also have macular degeneration or other conditions that impair their vision. Driving means independence and most people want to hold on to their cars as long as possible. When is it time to stop?
We’ve known for a long time that nutrition plays a role in macular degeneration. While we don’t have all the answers yet, new information keeps adding to our understanding.
Does alcohol affect AMD? For years, research has hinted that red wine may actually help, but beer may be something to avoid.
Stress can contribute to many health issues - creating them, making them worse, or just making it harder to cope with them. Some people with macular degeneration mention that they feel their vision is worse when they are very stressed.