Potential Treatments for Macular DegenerationMany potential treatments for macular degeneration are being investigated in laboratories and tested in human clinical trials. On this page, you will find the following:
AcupunctureEvaluated for: Dry age-related macular degeneration (AMD) How it works: This traditional Chinese practice involves inserting fine needles into specific points on the body and manipulating them in order to achieve a therapeutic effect. Recently, acupuncture has been studied in the context of macular degeneration. The needles are thought to stimulate blood flow to the retina, which prevents the buildup of debris that eventually leads to the death of light-sensitive cells and the loss of vision. Most common side effects: Common adverse effects may include slight bleeding, hematoma (a collection of blood outside the blood vessels), dizziness, and other vegetative symptoms such as fatigue and generalized sweating. Status: Acupuncture has not yet been proven a safe and effective means by which to prevent and/or treat dry AMD in a clinical trial. Therefore, acupuncture is not FDA-approved and it is not covered by Medicare or other insurance providers. AlprostadilBeing evaluated for: Dry age-related macular degeneration (AMD) How it works: Dry AMD patients may demonstrate reduced blood flow to the retina, which might contribute to the death of light-sensing cells. A subset of prostaglandins has been shown to increase blood flow. One of these is the prostaglandin PGE1. One clinical trial has been designed to test the effect of PGE1 treatment (Alprostadil) on visual acuity in dry AMD patients. The concept is that PGE1 will increase blood flow, and thus oxygen and nutrients to the retina, preventing cell death and vision loss. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: Alprostadil is currently in Phase III clinical trials and is currently recruiting participants in Europe. ARC1905Being evaluated for: Wet and dry age-related macular degeneration (AMD) How it works: The complement cascade is involved in the development of drusen and the progression of dry AMD. Ophthotech Corporation has developed a compound, ARC1905, that inhibits the complement cascade by blocking complement component 5. They want to test the ability of this compound to prevent the progression of dry macular degeneration. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: ARC1905 is currently in Phase I clinical trials and is currently recruiting patients. AREDS2Being evaluated for: Dry age-related macular degeneration (AMD) How it works: Evidence suggests that lutein, zeaxanthin, and omega-3 long chain polyunsaturated fatty acids (LCPUFAs) may be capable of altering the processes implicated in the progression of dry macular degeneration. AREDS2 may show promise as a well-tolerated preventive intervention. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: In June 2008, the National Institutes of Health began conducting AREDS2 Phase 3 trials in order to continue the study on dry AMD progression. AvastinEvaluated for: Wet macular degeneration How it works: Avastin has been approved by the U.S. Food and Drug Administration (FDA) as a blood vessel growth inhibitor used to treat colorectal cancer, but is not approved for macular degeneration. Avastin is manufactured by the same pharmaceutical company, Genentech, Inc., that makes Lucentis®, which was approved by the FDA in 2006 as a therapy for wet macular degeneration. Lucentis is actually a form of Avastin developed by Genentech to specifically treat macular degeneration through the use of smaller molecules for increased penetration of the retina. Both are similarly administered through a series of injections into the vitreous portion of the eye (the clear jelly-like substance that fills the eye from the lens back to the retina) at regular intervals over the course of months or a year. While Lucentis costs approximately $2,000 per injection, each Avastin treatment costs between $20 and $100, and many physicians believe both drugs are equally effective. Since much smaller doses of Avastin are used for macular degeneration than for cancer treatment, physicians normally use a compounding pharmacy to obtain the correct dosage. Most common side effects: Since Avastin is not intended for treating wet macular degeneration, side effects are not fully known. It is likely that side effects from Avastin are very similar to those of Lucentis. Common side effects of Lucentis include eye irritation, high blood pressure, and eye pain. Status: Physicians have been using a drug called Avastin® as an “off-label” treatment for wet age-related macular degeneration, with promising results. BevasiranibEvaluated for: Wet age-related macular degeneration (AMD) How it works: Bevasiranib was developed by Acuity Pharmaceuticals, and is now in clinical trials. Current treatments, such as Lucentis®, and Bevasiranib both target Vascular Endothelial Growth Factor (VEGF), a protein that promotes blood vessel growth in wet macular degeneration. However, Bevasinirab is an interfering RNA rather than a VEGF antagonist (e.g., Lucentis, which contains antibody fragments that bind to and inhibit VEGF activity). As a small interfering RNA (siRNA), Bevasiranib “silences” the genes that produce VEGF, and thus, slows the growth and leakage of abnormal blood vessels. Bevasiranib is injected directly into the eye, but less frequently than current VEGF antagonist treatments. Most common side effects: Swelling and inflammation at the injection site. No adverse side effects have yet been reported; however, this experimental drug is still in clinical trials. Status: Phase II clinical trials of Bevasiranib were completed in late 2006. In January 2008, recruiting began for Phase III trials. These trials will examine the safety and efficacy of administering three Lucentis injections, followed by injections of Bevasiranib every 8-12 weeks. The study should be completed in 2010. CopaxoneBeing evaluated for: Dry age-related macular degeneration (AMD) How it works: Copaxone is a compound that has been shown to reduce the number of harmful plaques in animal models of Alzheimer’s disease. The drusen that develop in the retinas of patients with AMD are similar to the plaques that develop in patients with Alzheimer’s disease. This finding is the basis of a clinical trial looking at the effect of weekly copaxone vaccinations for the treatment of dry AMD. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: Copaxone is currently being studied in Phase II and Phase III clinical trials. Cortical ImplantsEvaluated for: Wet age-related macular degeneration (AMD) How it works: Similar to the retinal implant, cortical implants collect and record images and convert them into visual stimuli that can be processed by the brain. Unlike those put into the retina, cortical implants bypass the eye altogether and are instead inserted into the part of the brain known as the visual cortex, which is responsible for processing visual signals sent from the eye. The patient must wear special head gear, a mini camera and sensor, that are connected to a computer and then to the implant. Most common side effects: Possible infection and swelling on or around the implant. Status: Cortical implants are still experimental, and research is continuing. Scientists need to find a material that is small enough, won’t be rejected by the body, and that can be used long-term. Source: This information was obtained in part from ClinicalTrials.gov and the National Eye Institute. DietSome studies indicate that eating a diet high in carotenoids, antioxidants (such as vitamins C and E), and omega-3 fatty acids may reduce the risk of developing age-related macular degeneration (AMD). However, more research is required before definitive statements can be made. Carotenoids are compounds found in plants, and have been associated with defending against age-related macular degeneration, cancer, heart disease, diabetes and a number of other medical conditions. Dark green, yellow and orange fruits and vegetables (especially those high in the carotenoids known as lutein and zeaxanthin), appear to best protect against development of age-related macular degeneration. Lutein and zeaxanthin are the primary pigments in the macula and are thought to guard the retina from ultraviolet light. These carotenoids normally occur together, in different ratios, in food. Lutein is found in dark, leafy greens such as spinach, collard greens and kale, as well as in okra, broccoli, papaya, oranges, kiwi, mango, green beans, peaches, sweet potatoes, lima beans, squash, red grapes and green bell pepper. Yellow corn, honeydew melon, squash, oranges, mango, kale, apricots, peaches and orange bell pepper are good sources of zeaxanthin. Fruits and vegetables abundant in vitamin C include green peppers, citrus fruits, tomatoes, broccoli, strawberries, yams, leafy greens and cantaloupe. Vitamin E is found in eggs, fortified cereals, fruit, wheat germ, green leafy vegetables, nuts/nut oils, vegetable oils and whole grains. Wild salmon, tuna, sardines, walnuts and flaxseed oil are good sources of omega-3 fatty acids. VitaminsThe National Eye Institute’s Age-Related Eye Disease Study (AREDS) found that taking a specific high dose formula of antioxidants and zinc (500 milligrams of vitamin C, 400 International Units of vitamin E, 15 milligrams of beta-carotene, 80 milligrams of zinc as zinc oxide and two milligrams of copper as cupric oxide) may delay or prevent intermediate macular degeneration from progressing to the advanced stage. There is no evidence, however, that the AREDS formula provided any benefit to people with early stage macular degeneration. Patients with intermediate macular degeneration in one or both eyes or advanced macular degeneration (dry or wet) in one eye but not the other eye should consider taking the formula. Consult a physician before taking any supplements; the AREDS formula may be contraindicated for certain medical conditions or may react negatively with some medications. The National Eye Institute is recruiting volunteers to participate in AREDS-2 trials. The study will focus on the effect of adding two supplements, lutein and zeaxanthin, as well as two omega-3 long chain fatty acids to the original AREDS formula. EculizumabBeing evaluated for: Dry age-related macular degeneration (AMD) How it works: The complement cascade is involved in the body’s immune response. In the retina, the complement cascade is involved in the development and progression of dry AMD. One study is exploring whether the inhibition of the complement cascade with eculizumab, a monoclonal antibody against complement component 5, has the ability to decrease the number and size of drusen, decrease the size of geographic atrophy, and improve visual acuity in patients with dry AMD. Eculizumab marketed as Soliris has been approved by the FDA for the intravenous treatment of paroxysmal nocturnal hemoglobinuria (PNH), an extremely rare blood disorder. Most common side effects: Side effects associated with eculizumab include: back pain; cough; fatigue; mild headache; nausea; nose, throat, or sinus irritation; tiredness and weakness. Certain severe side effects have also been reported with the use of eculizumab. These include: severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain or tenderness; chest pain; confusion; coughing up blood; eyes sensitive to light; fever, chills, or persistent sore throat; mental changes; moderate to severe headache along with nausea, vomiting, fever, stiff neck or back; mouth sores or fever blisters; severe muscle aches with flu-like symptoms; shortness of breath; unusual tiredness or weakness. Status: Eculizumab is currently in Phase II clinical trials. FenretinideBeing evaluated for: Dry age-related macular degeneration (AMD) How it works: In April 2009, Sirion Therapeutics Inc. announced that one of their compounds, fenretinide, demonstrated positive preliminary results in a clinical trial of dry AMD involving geographic atrophy. Fenretinide is a visual cycle inhibitor that can be taken by mouth and prevents the buildup of toxic substances in the retina that contribute to the development of drusen, and eventually geographic atrophy. Eighteen months into the study, Sirion reported that patients treated with the highest dose of fenretinide demonstrated a 45% reduction in the growth of geographic atrophy lesions. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: Fenretinide is currently being studied in Phase II clinical trials. Implantable Miniature TelescopeYear Approved by the FDA: Approval was expected in late 2007, but did not occur. Evaluated for: Advanced or end-stage age-related macular degeneration (AMD) How it works: The Implantable Miniature Telescope (IMT) was developed by Dr. Isaac Lipshitz of VisionCare, Inc. It may help those with end-stage wet macular degeneration gain back some vision. The IMT is a very tiny telescope that is inserted into one eye. The eye with the implant provides central vision (the area of vision lost in macular degeneration), while the other eye provides peripheral vision. The telescope projects images over healthy areas of the retina, rather than those damaged by the disease. The IMT can usually be implanted by an eye surgeon during an outpatient surgical visit. After surgery, patients must participate in a structured vision rehabilitation program to become accustomed to performing daily activities using the device. Most common side effects: There may be temporary changes in the pressure inside the eye, inflammation on or around the device and corneal swelling. Status: The Ophthalmic Devices Panel of the U.S. Food and Drug Administration (FDA) recommended approval of a second generation implantable telescope, the Lipshitz Macular Implant (LMI), on March 27, 2009. Macular TranslocationEvaluated for: Wet age-related macular degeneration (AMD) How it works: In wet macular degeneration abnormal blood vessels grow under the retina, often leaking and causing scarring of the macula, the portion of the retina responsible for sharp, clear, "straight-ahead" vision. This damage to the macula may eventually become permanent, but it usually only affects the macular region leaving the surrounding retinal tissue healthy. In macular translocation surgery, the macula is moved away from the damaged area and placed in a new, healthier location. The aim of this surgery is to try to maintain or recover some central vision. This surgery normally works best when vision loss is recent. Healing after the procedure may take several months. However, most patients experience some improvement in vision. A second corrective surgery may be needed to reposition the muscles of the eye, as moving or repositioning the macula can cause double or tilted vision. Most common side effects: The risks include cataract formation, infection, bleeding within the eye, retinal detachment, reduced vision and total vision loss. Status: Macular translocation surgery is still an experimental procedure. Micro-Electrical StimulationEvaluated for: Dry age-related macular degeneration (AMD) How it works: Micro-Electrical Stimulation involves placing small electrodes on the affected portion of the body, and running electrical current through the tissue, resulting in relief from pain. Recently, micro-electrical stimulation has been suggested to be an acceptable way to treat early stage AMD. Using a small, hand-held device, the patient will administer current to electrodes placed on the skin, around the eye’s nerves. The current is thought to stimulate the removal of sight-threatening waste products and facilitate repair of the macula. Most common side effects: Potential side-effects may include: electrical burns if electrodes are not applied properly or if current is too high; with repeated application, dermatitis and skin irritation may occur at the electrode sites. Status: Micro-electrical stimulation (Micro-current stimulation) devices currently advertised in the United States do not have FDA premarket approval for the indication of macular degeneration. However, the Transcorneal Electrical Stimulation Therapy study seeks to apply micro-current stimulation non-invasively (through the eyelids) to macular degeneration patients, and assess its capacity to improve visual acuity. This study is currently enrolling participants by invitation only. NT-501Being evaluated for: Dry age-related macular degeneration (AMD) How it works: In March 2009, Neurotech Pharmaceuticals Inc. announced that one of their compounds, NT-501, showed positive results in a clinical trial of dry AMD involving geographic atrophy. NT-501 is a compound that is implanted in the back of the eye. It contains human cells that have been designed to produce and secrete ciliary neurotrophic factor (CNTF), which is capable of preventing the death of light-sensing cells in the retina. Preventing the death of light-sensing cells is hypothesized to prevent vision loss in patients with dry AMD. A phase I clinical trial showed that NT-501 treatment was well tolerated with variable, but positive improvements in visual acuity. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: NT-501 is currently being studied in phase II clinical trials. PhotobiomodulationBeing Evaluated for: Dry age-related macular degeneration (AMD) How it works: Photobiomodulation is the application of non-thermal, non-laser light of specific wavelengths and energy directly to the eye. Photobiomodulation is thought to improve retinal function and delay dry AMD progression. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: Photobiomodulation is currently in Phase II clinical trials, and The Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration (TORPA) is currently recruiting participants. Radiation TherapyEvaluated for: Wet age-related macular degeneration (AMD) How it works: Numerous studies have reported the benefits of laser photocoagulation therapy for the treatment of wet macular degeneration. However, photocoagulation cannot be used for those with “subfoveal” macular degeneration in which the abnormal blood vessels are located under the fovea, in the center of the macula. Since almost 90% of age-related macular degeneration is subfoveal, scientists are searching for alternative treatment options for these cases. One option is radiation therapy in which a low-dose of radiation is used to inhibit the growth of abnormal blood vessels and subsequent scar formation. Although the exact mechanism is not fully understood, researchers believe that radiation causes abnormal vessels to regress and likely promotes cell inactivation to inhibit growth of new vessels. Fluid and blood are reabsorbed, reducing the risk for further leakage or bleeding. Radiation treatment can potentially stabilize and/or preserve vision and prevent of progression to advanced stage macular degeneration. Most common side effects: Macular scarring, subsequent abnormal vessel growth and/or hemorrhage. Status: Several clinical studies have reported that wet macular degeneration patients who receive radiation therapy seem to benefit significantly. In 2008, a Phase III clinical trial called CABERNET began recruiting participants. CABERNET will test the effectiveness and safety of a one-time dose of Strontium 90 beta radiation (through the Epi-Rad90™ Opthamalic System developed by NeoVista™, Inc.) combined with several injections of Lucentis®. This trial is expected to end in 2011. RetaaneEvaluated for: Wet age-related macular degeneration (AMD) How it works: Retaane (anecortave acetate) is an angiostatic cortisene designed to inhibit the new, abnormal blood vessel growth (angiogenesis) that occurs in wet macular degeneration. This investigational drug was developed by Alcon®. It is administered behind the eye to the surface of the sclera using a blunt-tipped, curved tube. The tube does not puncture the eye, so the procedure reduces the risks associated with the injection of compounds into the eye including infection and retinal detachment. Retaane is also administered less often than currently available angiogenic inhibitors – it is usually given once every six months. Most common side effects: No adverse side effects have yet been reported; however, this experimental drug is still in clinical trials. Status: In September 2007, upon completion of some clinical trials on Retaane, the Food and Drug Administration (FDA) informed Alcon that the drug was “approvable”, but that further trials were necessary before final approval. Alcon stated they did not plan to begin more trials due to difficulties finding volunteers and the availability of other macular degeneration therapies. In July 2008, after an interim analysis of study data, Alcon terminated a program evaluating the effect of Retaane on the risk of blood vessel development associated with macular degeneration. Alcon will continue to study Retaane as an eye-pressure lowering glaucoma therapy. Retinal ImplantsEvaluated for: Wet age-related macular degeneration (AMD) patients with moderate to severe vision loss. How it works: Retinal implants, also known as artificial retinas, are designed to replace lost photoreceptors (the light-sensing cells of the eye) and other retinal tissue damaged by abnormal vessel growth and scarring associated with wet macular degeneration. In most devices, a small video camera is mounted to a pair of eyeglasses. The camera collects images and sends this visual data to microelectrodes implanted in the retina of the eye. The microelectrodes, in turn, send electrical impulses to the part of the brain that can process the visual signals. Most common side effects: Infection and retinal detachment may occur. Other side effects may vary from patient to patient depending on the eye’s ability to tolerate the implanted device. Status: Though still in the testing and development stages, these devices may help those with advanced macular degeneration who have lost all or most of their vision. A few volunteers have already received retinal implants and are able to detect light and distinguish between some objects; further trials are planned. Numerous researchers at various institutions and universities worldwide are investigating retinal implants, including groups at the U. S. Department of Energy, the Doheny Eye Institute (University of Southern California) and the Boston Retinal Implant Project at Harvard and MIT. Further studies are needed to determine the optimal location for implant placement, and to find a material compatible with the normal eye tissue for long-term use. Retinal TransplantationBeing evaluated for: Dry age-related macular degeneration (AMD) How it works: The patient will receive retinal transplant tissue from human fetal retinas, with the hope that the transplants will make up for the death of light-sensitive cells in the retinas of macular degeneration patients. Most common side effects: Currently, side effects are unknown. Status: This highly experimental research is in Phase II clinical trials and is currently recruiting patients. RheopheresisEvaluated for: Dry age-related macular degeneration (AMD) How it works: Rheopheresis or the RHEO™ procedure has been tested for use in treating dry macular degeneration. In this procedure, the blood is removed from the body through an IV, filtered and returned. The filtering is an attempt to remove large molecules of certain substances (e.g., cholesterol, large proteins and fatty particles) that may lead to the progression of macular degeneration. These substances are thought to reduce the flow of blood to areas of the eye critical for vision. By removing these substances and improving blood flow to the eye, RHEO is believed to increase the supply of oxygen and nutrients necessary for macular cell health. Most common side effects: Hypotension (low blood pressure), nausea, dizziness, fainting and bruising at the sites of IV insertion. Status: In early 2007, the Food and Drug Administration cleared the way for Phase III trials of RHEO. However, due to current financial problems within OccuLogix, the company that developed RHEO, these trials have been suspended indefinitely and are not recruiting volunteers. Data is still being analyzed from two previous trials of RHEO. In 2007, researchers in Vienna, Austria began recruiting participants for a Phase III trial studying rheohemapheresis (same procedure) in conjunction with lutein supplements. RN6GBeing evaluated for: Dry age-related macular degeneration (AMD) How it works: Amyloid beta is a protein that accumulates in the brains of individuals with Alzheimer’s disease. Amyloid beta is the main constituent of the harmful plaques that develop in animal models of Alzheimer’s disease. The drusen that develop in the retinas of patients with AMD are similar to the plaques that develop in patients with Alzheimer’s disease. Pfizer has developed an antibody against amyloid beta, RN6G. RN6G decreased the amount of amyloid beta in the eyes of mice exposed to a model of AMD. These findings are the basis for a clinical study looking at the effect of systemic RN6G on the progression of dry AMD and geographic atrophy. Most common side effects: This treatment is currently in clinical trials in order to assess therapeutic potential and determine possible side effects. Status: RN6G is currently in Phase I clinical trials and is currently recruiting participants. RPE TransplantationBeing Evaluated for: Dry age-related macular degeneration (AMD) How it works: A small clinical trial has shown that it is possible to transplant a sheet of RPE and retinal cells from a healthy eye into an eye with AMD, and that these cells may be able to improve visual acuity in AMD patients, but vision may decline after the treatment. Most common side effects: Rejection of RPE transplant. Status: RPE transplantation may be a promising therapeutic treatment, and is currently recruiting participants to take part in future clinical trials. Stem Cell TransplantationBeing Evaluated for: Dry age-related macular degeneration (AMD) How it works: Stem cells are cells that have the ability to differentiate into a diverse number of cell types. Scientists have been able to isolate human stem cells, and have shown that they have the capacity to become incorporated into the retina in animal models of retinal degeneration. The incorporated cells may then become rods and cones, the light-sensitive cells that are affected in AMD. Most common side effects: Stem cell transplantation is still highly experimental and potential side effects have not yet been determined. Status: Stem cell transplantation appears promising, and may someday provide a way to prevent and restore the vision loss associated with dry AMD. Submacular SurgeryEvaluated for: Wet age-related macular degeneration (AMD) How it works: In submacular surgery for wet macular degeneration, lesions associated with bleeding beneath the retina, abnormal blood vessels and scar tissue are removed, rather than sealed or partially destroyed. It was believed that surgery to remove abnormal vessels might halt enlargement of the visual defect, spare the cells in the central macula, and allow the surrounding or adjacent tissue to function normally. Most common side effects: Cataract formation, macular holes and retinal detachment. Status: From 1997 to 2003, the National Eye Institute (NEI) sponsored the Submacular Surgery Trials (SST). Upon completion of the trials, in November 2004, the NEI reported that vision did not substantially improve for patients with macular degeneration who underwent submacular surgery. Disclaimer: The information provided in this section is a public service of the American Health Assistance Foundation, and should not in any way substitute for the advice of a qualified healthcare professional and is not intended to constitute medical advice. Although we take efforts to keep the medical information on our website updated, we cannot guarantee that the information on our website reflects the most up-to-date research. Please consult your physician for personalized medical advice; all medications and supplements should only be taken under medical supervision. The American Health Assistance Foundation does not endorse any medical product or therapy. Source: This information is sourced from ClinicalTrials.gov and the National Eye Institute. A special thanks to Susan Yanni and Jayakrishna Ambati, M.D. for contributing to and thoughtfully reviewing the content on this page. Last Reviewed On: 02/17/10 |
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