Saturday, January 3, 2009

Common Treatments for Macular Degeneration

In this section, you will find information on:

* Angiogenesis Inhibitors
* Laser Photocoagulation
* Photodynamic Therapy
* Vitamin and Mineral Supplements

Angiogenesis Inhibitors

Angiogenesis Inhibitors are used to treat the wet form of macular degeneration. The two most commonly used are Lucentis® (ranibizumab injection) and Macugen® (pegaptanib sodium injection).

Lucentis®

Generic name: ranibizumab injection

Year approved by the FDA: 2006

Effective for: Wet age-related macular degeneration (AMD)

How it works: Vision loss in wet AMD 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 AMD, 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 AMD, but is actually an FDA-approved cancer therapy. Both drugs are similarly administered. However, Avastin costs much less, and many physicians believe these drugs are equally effective. The National Eye Institute of the National Institutes of Health is planning to conduct clinical trials in 2008 (Comparison of Treatments Trials or CATT) to study the relative efficacy and safety of Avastin and Lucentis.

Macugen®

Generic name: pegaptanib sodium injection

Year approved by the FDA: 2004

Effective for: Wet age-related macular degeneration (AMD)

How it works: Vision loss in wet AMD 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 AMD, 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.

Laser Photocoagulation

Year approved by the FDA: 1991

Effective for: Wet age-related macular degeneration (AMD)

How it works: Photocoagulation was the first treatment that was used for wet AMD. 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” AMD 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.

Photodynamic Therapy

Visudyne® Generic name: verteporfin

Year approved by the FDA: 2000

Effective for: Wet age-related macular degeneration (AMD)

How it works: Photodynamic therapy (PDT) using Visudyne ® (verteporfin) is widely used to treat the new growth of fragile and abnormal blood vessels or neovascularization that is characteristic of wet AMD. PDT is most effective for a subtype of AMD called predominantly classic subfoveal, 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 AMD 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 3 months and as many times as needed to prevent re-growth of the abnormal vessels (potentially 6-7 treatments over 2-3 years). One treatment normally takes about 20 minutes and is relatively painless.

Most common side effects: The most common side effects of PDT include headache, injection site reaction, 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.

Vitamin and Mineral Supplements

Year approved by the FDA: The Food and Drug Administration (FDA) regulates dietary supplements under a different set of regulations than those covering conventional foods and drugs (prescription and over-the-counter). Dietary supplement manufacturers are responsible for ensuring that a dietary 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 FDA nor get FDA approval.

Effective for: Intermediate dry age-related macular degeneration (AMD)

How it works: Currently, there is no treatment or cure for dry 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 (AREDS formula) significantly reduced the risk of progressing from intermediate macular degeneration to advanced or wet macular degeneration. The study showed no benefit for those with early stage macular degeneration.

When 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 macular degeneration in one or both eyes or advanced macular degeneration in one eye but not the other eye 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. 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 currently recruiting 4,000 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 (DHA and EPA) to the original AREDS formula. Researchers are interested in the effect of these supplements on the progression to advanced 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 to the original AREDS formula. Scientists will follow up for at least five years.


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: 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. The American Health Assistance 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 Reviewed On: 11/21/08

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