Treatments for Macular Degeneration
Most of the common treatments described here impact wet macular degeneration. It is important to note that there is currently no specific treatment for dry macular degeneration; however, taking a specific high-dose formula of vitamins and mineral supplements (the “AREDS” formula) can significantly reduce the risk of progressing from intermediate dry macular degeneration to advanced or wet macular degeneration.
If you are diagnosed with this degenerative eye disease, you will need to see your eye doctor on a regular basis to determine how quickly your disease is progressing. Your doctor can tell you how to control risk factors for the disease, and he or she can also show you how to use the Amsler grid, which is a simple method by which you can regularly monitor and detect any subtle changes in your vision on your own. At the first sign of any visual changes, no matter how small they may seem, you should make an appointment with your eye care provider
On this page, you will find the following:
Treatments
Risk Reduction
Angiogenesis Inhibitors
Angiogenesis inhibitors are used to treat the wet form of age-related macular degeneration, including EYLEA™ (aflibercept injection), Lucentis® (ranibizumab injection), Avastin® (bevacizumab injection), and Macugen® (pegaptanib sodium injection).
EYLEA
Generic name: aflibercept injection, also known as VEGF Trap-Eye
Year approved by the FDA: 2011
Effective for: Wet age-related macular degeneration
How it works: Vision loss in wet age-related macular degeneration is caused by the growth of abnormal, leaky blood vessels that eventually damage the macula (area of the eye responsible for central vision). EYLEA is a protein engineered to block both vascular endothelial growth factor (VEGF) and Placental Growth Factor, two proteins that promote abnormal blood vessel growth.
EYLEA is "intravitreally" injected into the vitreous portion of the eye (the clear jelly-like substance that fills the eye from the lens back to the retina). In age-related macular degeneration, VEGF is continually produced, so ongoing, routine administration of EYLEA is required. However, the main difference in the treatment regimen of EYLEA versus other angiogenesis inhibitors is that after an initial 3-month period of injections every 4 weeks, EYLEA can be administered every 8 weeks. As a contrast, treatments with Lucentis and Avastin are normally given every 4 weeks and Macugen every 6 weeks, although the actual number of injections needed is determined by the physician and the individual patient's disease status and response to treatment. EYLEA's manufacturer, Regeneron, believes the decrease in treatment frequency will mean fewer doctor visits, decreased cost, and greater convenience for the individuals receiving the injections.
The safety and effectiveness of EYLEA was evaluated in a clinical trial in North America (called VIEW1) and in a clinical trial in Europe, Asia Pacific, Japan, and Latin America (called VIEW2).
People in the studies received either EYLEA or Lucentis (ranibizumab injection). In comparison to Lucentis, all EYLEA treatment groups had a similar, consistent average improvement in visual acuity (lost no more than 15 letters or 3 lines on a vision chart), and a similar, generally favorable safety profile. The recommended dose for EYLEA is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
Most-common side effects: Common side effects (5%) of EYLEA include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure (increases in pressure have been seen within 60 minutes of injection). There is an increased risk for endophthalmitis (an infection from bacteria or other organisms that develops inside the eye) and retinal detachments, as can follow any intravitreal injection. In addition, EYLEA is contraindicated for people with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the inactive drug additives present in the EYLEA preparation. The full prescribing information for EYLEA can be obtained from the manufacturer's website.
Manufacturer's medical and patient inquiries: Regeneron at 1-855-EYELA-4U (1-855-395-3248).
Status: Regeneron and Bayer HealthCare are collaborating on the global development of EYLEA™ (aflibercept) injection for the treatment of neovascular age-related macular degeneration (wet AMD) and has been approved by the US FDA. The companies are also studying the use of EYLEA for the treatment of other eye diseases and disorders including central retinal vein occlusion (CRVO), and diabetic macular edema (DME), however these other indications have not yet been evaluated by regulatory authorities. Bayer submitted an application for marketing authorization in Europe for wet AMD in June 2011.
Bayer HealthCare will market EYLEA™ (aflibercept injection) outside the United States, and Regeneron maintains exclusive rights to EYLEA in the United States.
Lucentis
Generic name: ranibizumab injection
Year approved by the FDA: 2006
Effective for: Wet age-related macular degeneration
How it works: Vision loss in wet age-related macular degeneration is caused by the growth of abnormal, leaky blood vessels that eventually damage the macula (area of the eye responsible for central vision). Lucentis is an antibody fragment that binds to and inhibits the activity of human vascular endothelial growth factor (VEGF), a protein believed to play a critical role in the formation of these new blood vessels. Lucentis is injected into the vitreous portion of the eye (the clear, jelly-like substance that fills the eye from the lens back to the retina). In age-related macular degeneration, VEGF is continually produced, so routine administration of Lucentis over a period of time is required.
Most-common side effects: The most commonly reported adverse events included hemorrhage of the conjunctiva (the membrane that covers the white part of the eye), floaters, eye pain, increased eye pressure, and inflammation of the eye. Serious adverse events such as endophthalmitis (severe inflammation of the interior of the eye), retinal detachment, retinal tear, increased eye pressure, and traumatic cataract are rare.
Status: Avastin, a drug manufactured by the same company that makes Lucentis (Genentech, Inc.), has been used by physicians as an "off-label" treatment for age-related macular degeneration, but is actually an FDA-approved cancer therapy. Both drugs are fragments of antibodies and are similarly administered. However, Avastin costs much less (refer to the section on Avastin). The National Eye Institute of the National Institutes of Health conducted clinical trials (Comparison of Treatments Trials or CATT) to study the relative efficacy and safety of Avastin and Lucentis. In May 2011, it was reported that Avastin and Lucentis were found to be nearly equally effective in treating AMD. In April 2012, CATT findings showed that the best results for maintaining visual acuity are achieved with injections every four weeks, with comparable results for either Avastin or Lucentis injected monthly. The report showed receiving doses of either drug “as needed” was less effective for maintaining visual acuity than with monthly dosing. Although Avastin was associated with a greater number of serious adverse events than Lucentis, the researchers could not determine whether these differences were due to statistical chance or to real differences between the safety profiles of the two drugs. Results from ongoing clinical trials worldwide may provide more information about the risks of taking Avastin relative to Lucentis for wet AMD.
Manufacturer's prescription assistance program: For more information on the clinical trial results that led to FDA approval for Lucentis, see the Ask An Expert answer to the question: “Although there is no cure, are there treatments available for age-related macular degeneration?”
Genentech at 1-866-4-ACCESS
Avastin
Generic name: bevacizumab injection
Effective for: Certain types of cancer. Used off-label 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 age-related macular degeneration. Lucentis is actually a form of Avastin developed by Genentech specifically to treat age-related 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 age-related 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.
The National Eye Institute of the National Institutes of Health conducted clinical trials (Comparison of Treatments Trials or CATT) to study the relative efficacy and safety of Avastin and Lucentis. In May 2011, it was reported that Avastin and Lucentis were found to be nearly equally effective in treating AMD. In April 2012, CATT findings showed that the best results for maintaining visual acuity are achieved with injections every four weeks, with comparable results for either Avastin or Lucentis injected monthly. The report showed receiving doses of either drug “as needed” was less effective for maintaining visual acuity than with monthly dosing. Although Avastin was associated with a greater number of serious adverse events than Lucentis, the researchers could not determine whether these differences were due to statistical chance or to real differences between the safety profiles of the two drugs. Results from ongoing clinical trials worldwide may provide more information about the risks of taking Avastin relative to Lucentis for wet AMD.
Status: Physicians have been using Avastin as an "off-label" treatment for wet age-related macular degeneration, with promising results.
Macugen
Generic name: pegaptanib sodium injection
Year approved by the FDA: 2004
Effective for: Wet age-related macular degeneration
How it works: Vision loss in wet age-related macular degeneration is caused by the growth of abnormal, leaky blood vessels that eventually damage the macula (area of the eye responsible for central vision). Macugen blocks vascular endothelial growth factor (VEGF), a protein that promotes this blood vessel growth. Macugen is injected into the vitreous portion of the eye (the clear jelly-like substance that fills the eye from the lens back to the retina). In age-related macular degeneration, VEGF is continually produced, so ongoing, routine administration of Macugen is required.
Most-common side effects: Common side effects of Macugen include inflammation of the eye, blurred vision or changes in vision, cataracts, bleeding in the eye, swelling of the eye, eye discharge, irritation or discomfort of the eye, and "spots" in vision.
Manufacturer's prescription assistance program: Eyetech at 1-866-272-8838
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Photodynamic Therapy
Visudyne®
Generic name: verteporfin
Year approved by the FDA: 2000
Effective for: Wet age-related macular degeneration
How it works: Photodynamic therapy (PDT) using Visudyne ® (verteporfin) is widely used to treat the new growth of fragile and abnormal blood vessels (neovascularization) that is characteristic of wet age-related macular degeneration. PDT is most effective for predominantly classic subfoveal, a subtype of age-related macular degeneration in which areas of abnormal blood vessel growth and bleeding in the fovea, at the center of the macula, are well defined. The great majority of cases are subfoveal, but only 25% of these cases are the predominantly classic subtype. During the PDT procedure, Visudyne, a light-sensitive drug, is injected into a vein in the arm. The drug enters the bloodstream and is absorbed by the abnormal blood vessels growing underneath the macula. A low-intensity, non-thermal ("cold") laser is then directed at the retina for a little over a minute. This activates the Visudyne, allowing it to destroy the abnormal vessels and inhibit the neovascularization. The cold laser does not damage the retina or other cell layers that overlie the abnormal vessels. PDT may help to stabilize vision, but it will not restore lost vision and is not likely to improve vision. Treatments are typically administered every three months and as many times as needed to prevent re-growth of the abnormal vessels (potentially six to seven treatments over two to three years). One treatment normally takes about 20 minutes and is relatively painless.
Most-common side effects: Some patients experience headaches, injection site reactions, and possibly blurred or reduced vision. Because the drug is activated by light, patients must avoid exposing their eyes or any part of their skin to sunlight or bright indoor light for up to five days after treatment.
Status: To date, the FDA has only approved Visudyne for PDT. Other light-sensitive drugs are being evaluated, and researchers are also studying the use of verteporfin in combination with other types of therapies. This treatment is not as commonly used as the angiogenesis inhibitors.
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Laser Photocoagulation
Year approved by the FDA: 1991
Effective for: Wet age-related macular degeneration
How it works: Photocoagulation was the first treatment that was used for wet age-related macular degeneration. During this outpatient procedure, the eye is numbed and a high-energy laser heats, seals, and destroys abnormal, leaky blood vessels. This can help prevent or slow further damage, but it results in a permanent blind spot. When successful, laser photocoagulation is a one-time treatment. However, if new blood vessels grow, surgery may have to be repeated.
Most-common side effects: Some patients experience mild pain during and shortly after the procedure. This is usually relieved by taking non-prescription pain medication. Reduced vision and scarring of the retina may also occur.
Status: It is not possible to treat those with "subfoveal" age-related macular degeneration, in which the abnormal blood vessels are located under the fovea, in the center of the macula. Almost 90% of AMD is subfoveal, so only a small percentage of patients are candidates for this procedure. This treatment is not as commonly used as the angiogenesis inhibitors.
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Implantable Miniature Telescope
Year approved by the FDA: 2010
Evaluated for: Advanced or end-stage, age-related macular degeneration
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 age-related 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 age-related 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: The CentraSight™ treatment program from VisionCare Ophthalmic Technologies using the IMT for end-stage AMD reports that the common risks of the telescope implantation surgery include inflammatory deposits on the device and increased eye pressure. Significant adverse events include corneal edema, corneal decompensation, corneal transplant, and decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen your vision rather than improve it. Discuss the potential risks and benefits of telescope implant surgery with your doctor.
Status: The FDA approved the second-generation implantable telescope in July of 2010.
Follow-up and monitoring: There are two ongoing, five-year, post-marketing (phase IV) clinical trials for VisionCare's IMT device, to study the long-term effects of implantation. (One trial is taking place in the United States and the other in the United Kingdom). For more information about these trials, visit www.clinicaltrials.gov (a service of the National Institutes of Health) and enter "implantable telescope eye" in the site search engine.
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Vitamin and Mineral Supplements
Dietary supplements are not approved by the FDA because the agency regulates them under a different set of regulations from those covering conventional foods and drugs (prescription and over-the-counter). Dietary supplement manufacturers are responsible for ensuring that a supplement is safe before it is marketed; the FDA may take action against any unsafe supplement after it reaches the market. Generally, however, manufacturers do not need to register their products with the FDA nor get FDA approval.
The AREDS formula is effective for: Intermediate dry age-related macular degeneration
How it works: Currently, there is no treatment or cure for dry age-related macular degeneration. However, in 2001, the National Eye Institute's (NEI's) Age-Related Eye Disease Study (AREDS) found that taking a specific high-dose formula of vitamins and mineral supplements (the AREDS formula) significantly reduced the risk of progressing from intermediate age-related macular degeneration to advanced or wet age-related macular degeneration. (The study showed no benefit for those with early-stage age-related macular degeneration.) When age-related macular degeneration progresses to the advanced stage, toxic substances build up that may damage the retina. The vitamins and minerals of the AREDS formula act as antioxidants to help maintain healthy cells and tissues and may prevent this damage.
In the study, the effective formula contained 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. Many of the antioxidants in the AREDS formula can be found in over-the-counter vitamin and mineral supplements, but the dosages required to achieve maximum efficacy are far greater. AREDS formula supplements may be contra-indicated with medications, and patients should consult a physician before taking any vitamins or minerals. Patients with intermediate age-related macular degeneration in one or both eyes, or advanced age-related macular degeneration in one eye but not the other, might consider taking the formula.
Most-common side effects: Some participants in the AREDS clinical trials reported minor side effects: a small percentage of those given zinc treatments developed urinary tract problems that required hospitalization; and yellowing of the skin, a well-known side effect of large doses of beta-carotene, was reported slightly more often by participants taking antioxidants.
Status: NEI is conducting the AREDS-2 clinical trials focused on the addition of lutein, zeaxanthin, and omega-3 fatty acids (DHA and EPA) to the original AREDS formula. Researchers are interested in the effect these supplements have on the progression to advanced age-related macular degeneration and/or moderate vision loss in those at risk of progression. Participants will also be offered variations on levels of beta-carotene and zinc that were included in the original AREDS formula. The reasons for this adjustment is that the zinc was thought to cause genitourinary problems that required hospitalization in a small percentage of the original AREDS trial participants, and beta-carotene supplementation is not recommended for consumption by smokers or ex-smokers due to the increased risk of lung cancer. The estimated AREDS2 trial data collection and primary outcome measure completion date is December 2012. Scientists will follow up for at least five years.
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Potential Treatments for Macular Degeneration
Many potential treatments for macular degeneration are being investigated in laboratories and tested in human clinical trials. For snapshots of current investigations, visit www.clinicaltrials.gov and enter one of the following terms in the search field: “macular degeneration” or “age-related macular degeneration” or “AMD” or “ARMD.” Clinicaltrials.gov is a database maintained by the National Institutes of Health that lists government- and privately-sponsored clinical trials conducted in the United States and around the world.
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Prescription Assistance Programs
The following section will provide you with financial assistance information for prescription medications.
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Disclaimer: The information provided is a public service of the BrightFocus Foundation and is not intended to constitute medical advice. It should not in any way substitute for the advice of a qualified healthcare professional. Please consult your physician for personalized medical advice; all medications and supplements should only be taken under medical supervision. BrightFocus Foundation does not endorse any medical product or therapy.
Source: The information provided in this section of our website was obtained from the National Eye Institute of the National Institutes of Health and ClinicalTrials.gov. BrightFocus Foundation is grateful to Jeffrey H. Stern, M.D., Ph.D. at the Regenerative Research Foundation in Rensselaer, New York for reviewing aspects of the above content.
Last Review: 04/26/13
