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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.

After numbing the eye, the doctor injects EYLEA into the clear, jellylike substance (the vitreous) that fills the eye from the lens back to the retina and then monitors the patient's progress. After an initial three-month period of injections every four weeks, EYLEA can be administered every eight weeks.

In comparison, treatments with the other angiogenesis inhibitors are normally given every four weeks (Lucentis and Avastin) or every six weeks (Macugen). The actual number of injections needed is determined by the physician, taking the individual patient's disease status and response to treatment into consideration.

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).

Most-common side effects: The most commonly reported side effects of EYLEA (affecting no more than fi ve percent of patients) include hemorrhage of the conjunctiva (the membrane that covers the white of the eye), eye pain, risk of cataract, vitreous detachment, vitreous floaters (specks or clouds moving in the field of vision), and increased eye pressure. There is a greater risk for endophthalmitis (severe inflammation of the eye interior) and retinal detachments, as can follow any injection into the vitreous. 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 after it has been numbed. Injections are given regularly over a period of time. The frequency and actual number of injections needed are determined by the physician and the individual patient's disease status and response to treatment. Findings from international studies announced in 2012 indicate that an injection every four weeks may be optimal.

Most-common side effects: The most commonly reported side effects of Lucentis include hemorrhage of the conjunctiva, floaters, eye pain, increased eye pressure, and inflammation of the eye. Rare but serious adverse events include endophthalmitis, retinal detachment, retinal tear, increased eye pressure, and traumatic cataract..

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.

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?

Manufacturer's prescription assistance program: 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 is an FDA-approved cancer therapy drug manufactured by the same company that makes Lucentis. Avastin has been used by doctors as an off-label treatment for AMD. Both drugs are similarly administered. However, Avastin is much less expensive, and many doctors believe these drugs are equally effective against macular degeneration. 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, they 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 that receiving doses of either drug "as needed" was less effective for maintaining visual acuity than 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.

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.

Status: Physicians have been using Avastin as an "off-label" treatment for wet age-related macular degeneration, with promising results.

Drug Safety Issues

Avastin, a drug approved for cancer treatment, must be divided into smaller doses for use as an eye treatment. This is done by licensed "compounding pharmacies." Although use of a compounding pharmacy is an accepted practice, currently the compounded medicines are not individually evaluated by the U.S. Food and Drug Administration.

The compounding procedure can also introduce the opportunity for bacterial contamination of a drug product. Although rare, there have been illnesses and even deaths due to poorly compounded drugs. Consult with your doctor about how your Avastin and other off-label drugs are prepared.

For the latest news on this and other drug safety issues, visit the news updates section of our website.

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 that has been numbed. It is usually administered every six weeks. The actual number of injections needed is determined by the physician, taking the individual patient's disease status and response to treatment into consideration. Macugen is still available for treatment of wet AMD, but is not used as often as other injectable angiogenesis inhibitors.

Most-common side effects: Common side effects of Macugen include inflammation of the eye, blurred vision, other changes in vision, cataracts, bleeding in the eye, swelling of the eye, eye discharge, irritation or discomfort of the eye, and "spots" in vision. Injection can also make the eye susceptible to infection for a period of time.

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) is most effective in a subtype of wet AMD called predominantly classic subfoveal choroidal neovascularization, in which blood vessel growth and leakage in the fovea—the small region in the center of the macula—are well defined. It should be noted that PDT is rarely used now that there are drugs (EYLEA, Lucentis, Macugen, and Avastin) that specifically block the vessel-promoting VEGF protein. During the PDT procedure, a drug called Visudyne® is injected into the arm. The drug courses through the body and is absorbed by the fragile, leaking blood vessels in the eye.

Because Visudyne is activated by light, the doctor directs a low-intensity laser at the retina for a little over a minute. This activates the Visudyne, allowing it to destroy the abnormal vessels. One treatment normally takes about twenty minutes and is relatively painless.

PDT may help to stabilize vision, but it will not restore lost vision.

Most-common side effects: The most common side effects of PDT include headache, injection site reaction, and blurred or reduced vision. Because the drug is activated by light, it is important to avoid exposing eyes or any part of the 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: Laser photocoagulation surgery was the first treatment used for wet AMD, but it is only an option for a small number of patients. During the outpatient procedure, the eye is numbed, and a high-energy laser heats, seals, and destroys abnormal leaky blood vessels. This can potentially prevent further vision loss, but it results in a permanent blind spot due to scarring.

Some patients experience mild pain during and/or shortly after the procedure. When successful, laser surgery is done once. 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: Approved by the FDA in 2010, the implantable miniature telescope (IMT) may help those with end-stage AMD gain back some vision.

In general, to be considered a potential candidate for the telescope implant an ophthalmologist must first confirm that you:

  • Have irreversible, end-Stage AMD resulting from either dry or wet AMD
  • Are no longer a candidate for drug treatment of your AMD
  • Have not had cataract surgery in the eye in which the telescope will be implanted
  • Meet age, vision, and cornea health requirements

The tiny telescope is inserted into one eye, which then provides central vision while the other eye provides peripheral vision. The telescope projects images over healthy areas of the retina. 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 learn how to perform 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: There is an intervention measure that could delay and possibly prevent intermediate age-related macular degeneration from progressing to the advanced stage in which vision loss occurs. However, once dry age-related macular degeneration reaches the advanced stage, there is no form of treatment at present to prevent further vision loss.

The National Eye Institute’s Age-Related Eye Disease Study (AREDS) found that taking nutritional supplements with a specific high-dose formulation of antioxidants (vitamins C and E and beta-carotene), zinc, and copper delayed or prevented the progression of age-related macular degeneration from the intermediate to the advanced stage.

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: A follow-up trial, called AREDS2, was completed in May 2013. In that study, researchers found that the addition of omega-3 fatty acids to the supplements did not improve the formula’s success. The antioxidants lutein and zeaxanthin proved safer than beta-carotene, which increases the risk of lung cancer for smokers or ex-smokers. Thus, the AREDS2 recommendation for the supplement formula is 500 milligrams of vitamin C, 400 international units of vitamin E, 10 milligrams of lutein, 2 milligrams of zeaxanthin, 80 milligrams of zinc, and 2 milligrams of copper.

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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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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: 08/29/13


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