by Dan Roberts
(Also available in audiovisual format)
This is my 10th annual summary of leading research and developments that have occurred during the past 12 months in the field of blindness and low vision. For more details about any of the reports, sources are provided.
Many studies and clinical trials are moving ever closed to treatments and cures for retinal diseases. This report will offer brief descriptions of the work done in the categories of pharmaceutical treatments, anti-VEGF and combination therapies for neovascularization, stem cell therapy, gene therapy, surgical procedures, new technology, diet and nutrition, daily living, and self-monitoring. And, as always, we will finish with a look at the promises of the future.
In a past report, I described a synthetic peptide, called POT-4, under development for treatment of the dry form of age-related macular degeneration (AMD). It has been shown to shut down the complement activation system that can lead to local inflammation, tissue damage, and the resulting blood vessel growth. POT-4 was the first complement inhibitor tested in patients with AMD.
Recently, the drug has been improved and renamed APL-2. APL-2 acts like the original compound, but it has a significantly improved half-life meaning that its effectiveness will last longer in the eye.
A Phase I clinical trial of APL-2 is underway with patients affected by wet AMD. It will be followed this year by a larger Phase II trial in patients with advanced dry AMD.
In past summaries, I have described several other drugs under study for treatment of dry AMD. You may read about these in the continually-updated “Guide to Research in Dry AMD”, to be found in the library of the Living Well With Low Vision website.
Blood Pressure Meds and AMD
The media reported last year that another association was discovered between development of AMD and use of blood pressure (BP) lowering medications. Before patients begin discarding their BP drugs, however, they should realize that an association between a drug and a disease means they have a relationship, not that the drug causes the disease.
Since 1987, a good amount of research has found a causative relationship between BP and AMD. It makes sense, therefore, that, since people with high BP are at risk of developing AMD, they are more likely to take vasodilators. This forms a relationship, but not a causative relationship, between the drugs and the disease.
The researchers themselves cautioned that their recent study was not able to discern effects of the medications themselves and high BP. Until further research is done to connect the cause to the effect, medications should not be adjusted without advice from a discerning professional.
Blood Pressure Meds and AMD
The color (pigmentation) of the retina, or lack thereof, is thought to play a role in the development of age-related macular degeneration (AMD). The substance that provides pigmentation is melanin, and a precursor to the pigment melanin is called L-DOPA. Since L-DOPA converts into dopamine in the brain, it has been used as a treatment for Parkinson’s disease. Now, researchers have hypothesized that it may also delay the onset and progression of AMD.
In a study investigating over 15 million people, individuals taking L-DOPA were significantly less likely to develop AMD, and when they did, the age of onset was significantly later. These results suggest L-DOPA may be useful in both preventing and delaying the disease.
L-DOPA is processed as an oral drug for Parkinson’s patients, and it is also available in herbal extracts and in some types of beans, particularly broad beans.
Inverse Association Between L-DOPA and Age-Related Macular Degeneration. (Abstract 2818-C0046, Association for Research in Vision and Ophthalmology, May 2015)
ANTI-VEGF THERAPY FOR WET (NEOVASCULAR) CONDITIONS
About anti-VEGF therapy
Since 2004, anti-VEGF therapy has been saving the sight of countless people who experience uncontrolled bleeding in the retina. VEGF is an acronym that stands for vascular endothelial growth factor. This is the substance in our DNA that is responsible for inflammation. Inflammation is a beneficial function of our bodies that is part of the normal healing process. It can, however, be harmful if it occurs in our retinas, and that is why anti-VEGF drugs are injected into the eyes of people with the wet form of AMD.
Before anti-VEGF treatments were available, wet AMD was the leading cause of visual impairment in people aged 50 years and older. A recent study showed that in patients who are treated with anti-VEGF for wet AMD, 9 out of 10 will have avoided blindness after 5 years of treatment, nearly 8 out of 10 will have avoided becoming partially sighted, and nearly 4 out of 10 will still be able to continue driving.
The Neovascular Age-Related Macular Degeneration Database: Multicentre Study Report 3: Trends in blindness and other degrees of sight impairment in ranibizumab-treated patients. Miranda Buckle (ARVO Abstract 1659)
Prediction of wet AMD onset
Until November, it was not possible to accurately predict the onset of wet AMD over the long term. A new method, however, predicts whether a patient’s vision would, if untreated, probably deteriorate more rapidly, due to retinal blood vessel growth and leakage, and approximately when that would occur.
Researchers have derived a formula that accurately distinguishes likely from unlikely progressors, such as the area and height of drusen, the amount of reflectivity at the macular surface, and the degree of change in these features over time. This data would be gathered from retinal scans and then analyzed. From the analysis, doctors would be able to generate a number (“risk score”) that predicts a patient’s likelihood of progressing to wet AMD within one, three, or five years. The researchers are now entering into a larger study with patients from other institutions to try duplicating the results.
Study May Lead to More Accurate Long-Term Prediction of Wet AMD
Easing the Burden of Treatment
Researchers are trying to ease the burden of frequent anti-VEGF injections. By doing so, they may lessen the risk of infection, avoid the problem of developing resistance, lower costs, and alleviate much of the psychological stress felt by many patients.
Encapsulated Cell Technology
- Implanting time release capsules is one procedure that has been showing promise in that area. In March 2015 that the FDA approved a Phase 2 clinical study of NT-503 Encapsulated Cell Therapy (ECT) for the treatment of wet AMD. This is an implant that is genetically engineered to produce the drug NT-503 inside of the eye for at least 2 years.
Encapsulated Cell Technology Could Replace Injections in Wet AMD Patients
Another device, called a MicroPump, is being developed to reduce the need for frequent injections. The device was initially designed for patients undergoing drug treatment for glaucoma. A second version is expected to benefit people with chronic diseases of the retina, such as diabetic macular edema and wet AMD. Due to its larger reservoir volume, it can be easily refilled for up to seven years of use.
The MicroPump™ is still in human trials, but it is showing promise as another way to lower risks of current injection protocols and greatly lessen the burden on patients who are undergoing multiple treatments.
MicroPump™: The Newest Drug Delivery System For Chronic Eye Disease
Resolution of Retinal Fluid
For those who have been undergoing anti-VEGF treatments, here is some encouraging news about how well it has been working. In a clinical trial for patients undergoing monthly treatment for wet AMD, researchers analyzed the time it took for fluid leaking into the retina to dry out. They found that 21% of patients dried out after one month, and 41% were dry by 3 months. These kinds of positive results were simply unheard of a decade ago. As a side note, they also found that different layers of the retina dried at different rates, and that Lucentis dried two of the three layers more quickly than off-label Avastin.
Resolution of Retinal Fluid on Optical Coherence Tomography in the Comparison of AMD Treatments Trials (CATT). Maxwell Pistilli (Abstract 1657)
Macular Atrophy Risk With CNV Treatment
I reported here last year that some doctors were concerned about anti-VEGF drugs potentially starving healthy cone cells by cutting off their nutrition supply. In other words, causing a hastening of geographic atrophy.
Two recent studies have concluded that the rate of geographic atrophy in treated patients was essentially no different than in untreated patients. On the other hand, a third study confirmed three earlier reports of a significant correlation between the number of intravitreal injections and the progression of geographic atrophy.
Looking at research during this past twelve months, it appears that this is still an ongoing concern that deserves more attention.
Macular Atrophy in Patients with Neovascular Age Related Macular Degeneration Undergoing Anti-VEGF Therapy. Nizar S. Abdelfattah (Abstract 892)
Evolution of Geographic Atrophy in Patients Treated with Ranibizumab for Neovascular Age-related Macular Degeneration. Alisa Thavikulwat (Abstract 891)
Progression of geographic atrophy in patients receiving anti-vascular endothelial growth factor for neovascular age-related macular degeneration (AMD): five year follow up. Nadezhda Cvetkova (Abstract 1515 – B0241
Cardio Risk With CNV Treatment
Scientists are continuing to monitor the potential for strokes resulting from anti-VEGF drug injections. This was a concern early-on when the Lucentis trials revealed a small (less than 3%) risk of stroke in subjects undergoing the treatment. We continue to be comforted by results such as those from a recent study of subjects with diabetic macular edema (DME). Results showed that the rates of arterial thromboembolic events (ATEs) were similar between Lucentis groups and control groups, and annualized ATE rates were consistent over time. This suggests that intravitreal injections of Lucentis in DME patients are not associated with an increased risk of ATEs.
Cardiovascular and cerebrovascular safety of ranibizumab 0.5 mg in diabetic macular edema. Marco A. Zarbin (Abstract 1410 – A0105)
Cost Comparison of Lucentis and Eylea
The anti-VEGF agents Lucentis and Eylea differ with respect to dosage and administration, which leads to differences in their cost and utilization in the clinics. A recent analysis, however, of commercial and Medicare supplemental data found that annual costs and number of injections were similar with these two treatments in patients with AMD and retinal vein occlusion (RVO). The research also found that the annual costs of treating diabetic macular edema patients with Lucentis were lower than for AMD and RVO patients.
This is interesting, in that cost is often the one deciding factor in choosing one of these drugs over the other.
A US Claims Analysis of Anti-VEGF Treatment Patterns in Neovascular Age-related Macular Degeneration, Retinal Vein Occlusion, and Diabetic Macular Edema. Michelle V. Carle (ARVO Posterboard A0100, Abstract 1405 – A0100)
COMBINATION THERAPIES FOR NEOVASCULARIZATION
Many studies have been trying to find ways to make anti-VEGF drug treatments more effective, longer-lasting, and safer. Three of those drugs have stood out during this summary period.
Dexamethasone is a powerful anti-inflammatory and immunosuppressive steroid medication that has been studied in combination with Lucentis over a 12-month period. The researchers found that adding dexamethasone to Lucentis treatment in persistent cases of wet AMD seemed to delay re-treatment. As a result, they concluded that this particular combination should be considered in selected cases.
Role of additional dexamethasone treatment for the management of persistent choroidal neovascularization secondary to age-related macular degeneration. Sandra Reza (Abstract 1280)
Dexamethasone was also introduced to subjects’ eyes in the form of implants injected into the eyeball. These subjects had macular edema from either central or branch retinal vein occlusion. The researchers reported that dexamethasone implants reduced levels of several proteins that may be responsible for weakened retinal vessels. This suggests that dexamethasone implants might potentially be an appealing multi-targeted approach for patients with macular edema.
Reduction of Macular Edema and Pro-permeability Factors after Dexamethasone Implant Injection in Retinal Vein Occlusion; the Ozurdex for Retinal Vein Occlusion (ORVO) Study. Tahreem A. Mir (Abstract 1282)
Triamcinolone acetonide (TA) is a sustained-release steroid that has been tested in combination with Lucentis. The drug lasts a long time in the eye with one injection, but it can result in clouding of the lens over time. Surgery to remove the clouded lens, however, has restored good vision.
Two Year Results of a Phase 1 Study of the Safety and Tolerability of Combination Therapy Using Sustained Release Intravitreal Triamcinolone Acetonide and at Baseline Followed by Anti-VEGF PRN Treatment for Subfoveal Neovascular AMD. (Abstract 1654)
A Phase II clinical trial of Squalamine eye drops has demonstrated a positive benefit in multiple visual function including a significant gain in visual acuity when administered along with Lucentis. A 65% additional relative benefit was seen as early as four weeks, and the benefit continues to increase throughout the study. The researchers plan to present the full data from this interim analysis in the second half of this year.
Positive Interim Results From Phase II Study of Eye Drops for Wet AMD
Final Results from a Phase 2 Study of Squalamine Lactate Ophthalmic Solution 0.2% (OHR-102) in the Treatment of Neovascular Age-related Macular Degeneration (AMD). Jason S. Slakter (Abstract 4805)
OTHER RETINAL DISEASES
With so much news about anti-VEGF treatment, one would think that scientists are focusing only on wet AMD and diabetes-related conditions. Other retinal diseases, however, are also getting their share of attention from pharmaceutical researchers.
Glaucoma is characterized by an increase in intraocular pressure (IOP), and multiple studies have reported short-term increased IOP after injection with anti-VEGF drugs. One group of scientists, therefore, hypothesized that patients with glaucoma might be predisposed to this problem, so they initiated a study to find out.
After looking at data from 42 patients, they did find that there is a trend towards increased IOP in patients with glaucoma relative to those without. The effect, however, appears to be of short duration. “Given this information,” they concluded, “there appears to be little benefit in pre-treatment with IOP lowering medications in patients with glaucoma who are also receiving intravitreal medications.”
Short Term Intraocular Pressure Changes After Intravitreal Injection in Patients with Glaucoma. Sabin Dang (ARVO Posterboard A0240, Abstract 2672 – A0240)
Central Serous Chorioretinopathy
Central Serous Chorioretinopathy (CSC) is a disease that affects mostly middle-aged males who tend to display Type A personalities. Stress is the common pathology, as it can cause an imbalance in the hormone cortisol, leading to central vision loss. The condition can be chronic, or it can resolve on its own after time. Possibly for this reason, there is not yet a universally accepted treatment protocol for patients with CSC, and no major trials have been conducted.
- One of the few treatments to come to the forefront is rifampin taken orally. It is normally used in cases of tuberculosis, but several reports have highlighted the medication’s efficacy in CSC, particularly in chronic cases. In a recent study, four patients experienced resolution of subretinal fluid and decreased visual distortion within 4-6 weeks of rifampin therapy.
Rifampin Therapy for Central Serious Chorioretinopathy. Alanna Nattis (ARVO Posterboard B0211. Abstract 3722 – B0211)
Spironolactone and eplerenone
Another study compared spironolactone and eplerenone, two oral cortisol blockers that have been used to treat CSC. Both were found to be effective, with spironolactone appearing to result in better anatomic outcomes and faster resolution of subretinal fluid.
Comparison of two mineralocorticoid receptor antagonists in the treatment of central serous chorioretinopathy. Paola Carrai (Abstract 1284)
Anti-VEGF drug injections are also part of the arsenal against CSC. They were designed to inhibit blood vessel growth and leakage, so it makes sense that they could also be effective in stopping serum leakage. And it is showing some success, such as in a recent report that off-label Avastin resulted in rapid improvement in visual acuity, where such improvement usually takes several months when letting resolution occur naturally.
Treatment of central serous chorioretinopathy using anti-vascular endothelial growth factor. Wael Abdelghani (ARVO Posterboard B0215, Abstract 3726 – B0215)
Focal Verteporfin Photodynamic Therapy
Photodynamic therapy involves targeting the affected area of the retina with a low-voltage laser that coagulates leaking vessels. This has been a conventional treatment for slowing the fluid build-up caused by CSC. More commonly, it has focused on the entire affected area, but a recent study has shown that focusing the laser on the specific source of the leakage was equally effective. This procedure and the pharmaceutical efforts may seem to be small contributions to the battle against CSC, but it is encouraging to know that work is being done in a field of study that has not received a lot of attention by comparison.
Comparison of Focal and Conventional Verteporfin Photodynamic Therapy for Chronic Central Serous Chorioretinopathy. Min Seok Kang (ARVO Posterboard B0213, Abstract 3724 – B0213)
Retinitis Pigmentosa and Leber’s Congenital Amaurosis
Some good news came this year for people affected by Retinitis Pigmentosa and Leber’s Congenital Amaurosis, both of which are caused by gene mutations often resulting in severe vision loss. In a recent study, repeated treatments with an oral synthetic cis-retinoid called QLT091001 led to sustained visual improvements in a large subset of affected patients. These diseases are caused by mutations of single genes, which places them high on the list for benefitting from genetic replacement therapy. For that matter, progress has already been made by successful restoration of sight in a young boy with Leber’s just a couple of years ago.
Vision Improvement After Retreatment with an Oral Synthetic cis-Retinoid (QLT091001) in Subjects with LCA or RP due to Mutations in RPE65 or LRAT. Hendrik P. Scholl (Abstract 1285)
Diabetic Macular Edema (DME)
- As anti-VEGF drugs are proving themselves in people with wet AMD, scientists are continuing to test them for treatment of diabetic retinopathy and diabetic macular edema, as well. During this past 12 months, both Lucentis and Eylea were approved for treatment of diabetic macular edema (DME).
Eylea Approved For Diabetic Macular Edema
FDA Approves Lucentis to Treat Diabetic Retinopathy in Patients With Diabetic Macular Edema
FDA Grants Priority Review for Lucentis in Diabetic Retinopathy
Iluvian and Ozurdex
Iluvian and Ozurdex are drug implants devised by two different companies for treatment of diabetic macular edema (DME). Both are corticosteroids that have demonstrated effectiveness in the treatment of DME without the need for monthly injections. Tiny implants injected into the eye’s vitreous gel release the steroids into the retina over a period of years, greatly relieving the burden of multiple clinic visits.
Ozurdex is also indicated for treatment of macular edema following retinal vein occlusion, and for the treatment of noninfectious uveitis.
Iluvian is also being studied as a treatment for dry AMD, but concerns by the FDA about safety and manufacturing standards have slowed its progress toward clinical trials.
Due to the high risk of cataract development and glaucoma, both of these extended-release steroid treatments are limited to adults without elevated intraocular pressure and those who either have undergone, or are scheduled for, cataract surgery. Both therapies are expected to be available in clinics this year.
FDA Approves Two Extended-Release Drug Therapies For DME
Long-term treatment with ILUVIEN fluocinolone acetonide (FAc) implants in patients with diabetic macular edema (DME). Baruch Kuppermann (only author) (Abstract 1283)
Early experience and outcome of Fluocinalone acetonide intravitreal implant (Iluvien) in the treatment of chronic diabetic macular oedema. Daniela Vaideanu-Collins (ARVO Posterboard A0168, Abstract 1735 – A0168)
STEM CELL THERAPY
Stem cell research continues to make the news, with two companies leading the research this past year, and a breakthrough happening just a month ago in Japan.
StemCells, Inc. announced that it had transplanted purified stem cells into the first five of eight patients in its Phase I/II trial for dry AMD. The trial has been enrolling patients at five centers in the US.
Stem Cell Trial Progressing
For over two years, Advanced Cell Technology, which last year changed its name to Ocata Therapeutics, has been conducting promising safety trials for stem cell treatment of AMD and Stargardt disease, but a six-month follow up has yielded even better news than expected.
Surprising even the researchers, the results showed that 10 of the 18 patients could see significantly better, 7 either got better or didn’t lose any more vision, and only one got worse. Not only is the procedure proving to be safe, but vision improvement is already evident.
The company has been working to initiate larger Phase 2 clinical trials soon for the treatment of both AMD and Stargardt disease. At the same time, Ocata has also treated the final Stargardt patient in the UK-based Phase 1 clinical trial, and they are now initiating stem cell trials for patients with myopic MD.
Stem Cell Trial Yields Surprising Results
Final Stargardt Patient Treated In Initial Stem Cell Trial
Stem Cell Trial for Myopic Macular Degeneration
Stem Cells From Skin
And finally, big news came out Japan this year, where researchers surgically transplanted into the eye of a woman a sheet of retinal pigment cells made from her own skin. This marked the first time stem cells from a person’s own body had been induced to become retinal cells implanted into a human.
Woman Receives Retinal Stem Cells Made From Her Own Skin
Combined with anti-VEGF therapy
In the area of gene replacement therapy, steady progress is being made toward eliminating or decreasing the frequency of anti-VEGF injections in treatment of neovascularization.
The therapy involves injecting a recombinant virus that continuously secretes a protein that inhibits blood vessel growth. The first 8 of 40 treated subjects have so far gained 6 to 9 letters on the acuity chart, compared to a loss of 3 letters in the untreated group. Using gene therapy in this way is different than usual, in that, rather than targeting a specific genetic disease, it is being used to treat a complex condition like wet AMD.
Gene Therapy Study For Wet AMD
Streamlining Stem Cell Production
Researchers have developed a technique that will streamline the production of stem cell derived tissues. By creating tissue more quickly, they would be able to cut costs in half and increase the output. This will help the researchers in their efforts to use patients’ skin cells to create new retinal tissue, and it will help scientists search for drugs for personalized treatments.
Gene Profiling Technique Accelerates Stem Cell Therapies for Retinal Diseases
FHL-1 Protein Deficiency May Cause AMD
I reported in the past about a compound called ocriplasmin (Jetrea), which has been developed to help relieve traction of the vitreous gel on the macula. Traction, or tugging, on the retinal tissue can cause holes and tears (rips) leading to necessary surgery and possible vision loss. Injection of ocriplasmin may be an effective alternative to vitrectomy surgery, so it is being studied intensely, with favorable results so far.
Clinical Results of Ocriplasmin For Symptomatic Vitreomacular Traction Syndrome. Anuj Chawla (ARVO Posterboard D0201, Abstract 1224 – D0201)
Extended Follow-up of Ocriplasmin for Vitreomacular Traction Release. David Dyer (ARVO Posterboard D0181, Abstract 1204 – D0181)
Much research has been conducted to determine the amount of risk of cataract surgery on retinas affected by wet AMD. Now, another study has been added to the stack to explore whether cataract surgery contributes to the progression of the disease.
As with past studies, cataract surgery did not appear to contribute to significant worsening of wet AMD, and it actually led to vision improvement. The risk was found to be no greater than in patients who did not have wet AMD. This further confirms the safety of cataract surgery in the hands of skilled and experienced surgeons.
Outcomes in wet age-related macular degeneration after cataract extraction. Steven Saraf (ARVO Posterboard A0221, Abstract 5372 – A0221)
Tinted IOL Debate
For several years, eye doctors have been debating the value of tinted intraocular lenses (IOLs) in eyes that have undergone cataract surgery. Those in favor of them argue that they reduce the retina’s exposure to potentially hazardous ultraviolet and blue light. The main argument against them is that they cause a decrease in dim light (scotopic) vision, which can be hazardous to the wearer. Now a recent study has demonstrated that there is no significant difference in visual acuity or macular changes between eyes implanted with UV- or blue-light filtering intraocular lenses. Of course, more study will be necessary to confirm those findings.
Study Shows No Difference Between Tinted and Clear IOLS
Improved Artificial Retina
An interdisciplinary team from Israel and Australia, is developing what they describe as an improvement over current artificial retinas.
The researchers combined semiconductor nanorods and carbon nanotubes to create a wireless, light-sensitive, more flexible, and more durable film that could potentially act in the place of a damaged retina. When they tested it with a chick retina that normally doesn’t respond to light, they found that the film absorbed light and, in response, sparked neuronal activity.
Currently available devices are restoring some vision to people who are profoundly blind. If successful in humans, nanotechnology may make the artificial retina more available to people with lesser visual impairments like macular degeneration.
A More Refined Artificial Retina Shows Early Promise (Living Well With Low Vision Library)
New Implantable IOL
And speaking of IOLs, a new implantable lens system has been developed that uses the technology used to improve the images from the Hubble Telescope. The new system’s nickname, therefore, is “Hubble Lens”. Another such device, the Implantable Miniature Telescope (IMT), has already been approved in the U.S. to address the problem of central vision loss. But the IMT requires a much larger incision through which the lens is implanted.
Another difference between the IMT and the Hubble Lens is that the IMT magnifies the visual field to encompass the peripheral vision, while the Hubble Lens redirects the image onto the peripheral retina without significantly magnifying it. Since the peripheral retina, however, does not offer the same clarity as does the macula, acuity with either lens system will be somewhat less than perfect.
“Hubble Lens” May Be Next IOL For AMD
Switchable Telescope Contact Lens
In 2013, Swiss researchers reported the results of their early work on a telescope that can be worn on the eyeball. Their work continues, as they attempt to overcome issues with unsatisfactory image resolution, contrast, and acuity. Another problem is that the device, made from rigid polymer, covers the entire front of the eyeball. This blocks air from reaching the eye, meaning that the telescopic lens can be worn for no longer than 30 minutes at a time. The wearer must also wear 3D-type glasses to make the magnification work, which may, for some, be cosmetically unappealing.
This may hold promise for some people with conditions like macular degeneration, where central vision needs accommodation. It may or may not be an improvement upon currently-used devices such as bioptic telescopes, hand-held miniscopes, and the recently approved implantable miniature telescope. The research is, however, welcome as yet another way to help the visually impaired.
What They Really Mean . . .
X. DIET & NUTRITION
New Omega-3 Finding
Researchers have demonstrated for the first time that the omega-3 fatty acids DHA and EPA can inhibit blood vessel growth in the retina. This is not to say, however, that more Omega-3 is better. According to MD Support’s nutrition advisors, it has been ultra-hyped in the media lately, and does not need to be consumed in high dosages. It does have healthy antioxidant properties, but we will wait for further research before considering it as a miracle treatment for neovascularization.
Omega-3 Inhibits Retinal Blood Vessel Growth
Another report from the past year deserves a second thought. Researchers found that tiny spherules of calcium phosphate known as hydroxyapatite, or HAP, may be an important “triggering factor” for AMD.
Some people might misconstrue this as a warning about consuming calcium. It is not, so people should make no changes in their diet or supplementation as a result of the finding. HAP deposits do not cause AMD. Rather, this research has found them to be collectors of lipid deposits, which form drusen, a known precursor of AMD in some people. By focusing on the spherules, therefore, doctors can perhaps detect early development of drusen and develop ways of stopping their build-up.
Does Calcium Cause AMD?
Medicare Coverage of Low Vision Devices
One of the few remaining obstacles for people with low vision is the lack of Medicare coverage for magnifiers and other such assistive devices. Legislation was introduced last year to fund a five-year project that would evaluate the fiscal impact of a change in this policy. Congress did not act upon it last year, so the bill was re-introduced to the new Congress this year. MD Support will continue to lobby in Washington for passage of this bill.
Legislation Re-introduced to Cover Medicare Payment for Low Vision Devices
Depression is a common risk for people who have lost their vision, but a new study showed that a new approach called “behavior activation” can cut the risk in half. The Low Vision Depression Prevention Trial (VITAL) was designed to test an approach to reducing disability through rehabilitation. Behavior activation is a multi-disciplinary treatment that bridges primary eye care, psychiatry, psychology, and rehabilitation. The trial results showed that behavior activation reduced the risk of depression by 50 percent compared to the control treatment.
New Approach to Low Vision Rehab Cuts Risk of Depression in Half
Degeneration of eyesight in patients with wet AMD can be treated with regular doses of an anti-VEGF injection. Maintenance of the treatment, however, is important between clinic visits, so several self-monitoring methods have been developed in addition to the traditional Amsler grid just for that purpose.
The Foreseen Home device allows patients to monitor daily at home to help detect when intermediate or late-stage dry AMD converts to wet AMD. Based upon the theory of hyperacuity, this system identifies areas of distortion in the visual field and will contact the patient’s doctor if significant changes occur.
My Vision Track
A similar self-monitoring method is an Internet-based application called My Vision Track, which uses the patient’s computer to test for vision changes.
The newest test is Hyperacuity App, an interactive application that runs on an iPad and can be used by the patient at home. Patients are alerted to when their eyesight has subtly but significantly changed, so they will be able to visit their ophthalmologist as soon as possible and receive treatment.
Handheld shape discrimination hyperacuity test on a mobile device for remote monitoring of visual function in maculopathy. Wang YZ (Invest Ophthalmol Vis Sci.2013 Aug 13;54(8):5497-505. doi: 10.1167/iovs.13-12037)
Evaluation of the Hyperacuity Application (HAC) on a Tablet Computer for Detecting Choroidal Neovascularization. Jessica Chen (ARVO Posterboard A0097, Abstract 1402 – A0097)
Stem Cell Therapy
We are all anxiously awaiting results from stem cell trials, and the future still holds promise for success with this treatment. Ocata Therapeutics, Inc. (formerly Advanced Cell Technology) announced in March that the company had completed dosing of its Phase 1/2 of its studies for dry AMD and Stargardt Disease. A total of 38 patients have been safely dosed, and that has paved the way for the next phase of the trials. If they can stay on schedule, we could be looking at the year 2017 for final FDA approval, with availability to the public a few months thereafter. This is cautious optimism, but even cautious optimism is better than none at all.
Phase 2 Stem Cell Trial To Be Initiated
Cars that drive themselves? Really? Not only have they been tested and found successful, but states are already working on insurance and legal issues that could make driverless automobiles a reality in just a couple of years. We are already seeing the technology incorporated into cars on the road today, and we will probably see the first real application in the form of taxis, followed in a few years by affordable private vehicles. This would virtually eliminate the most serious problem caused by vision loss: transportation whenever and wherever we feel like taking a ride.
So on that positive note, I’ll bring this year’s summary to an end. Please pass this along to anyone you know who might benefit from knowing about all of the progress being made on behalf of our low vision community. We are grateful to the doctors, researchers, and organizations whose hard work will someday bring the treatments and cures that will put an end to vision loss.