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Treatment Options for Wet Macular Degeneration (MD) The first point of contact for treatment options should be with your eye specialist. In many cases this will be a retinal specialist. You should always discuss any concerns, questions or information you have obtained with your specialist. They are in the best position to advise you on your treatment options. Wet MD occurs when abnormal blood vessels grow into the retina and leak. This process is called choroidal neo-vascularization (CNV). Neo = new and vascularization = vessel formation. There are currently 3 areas of treatment available for people with wet MD: • Treatments proven to be effective by controlled trials published in peer review journals • Treatments proven to be effective by controlled trials but not yet published in peer review journals • Experimental treatments The treatments are not curative and aim to keep the best vision for as long as possible. TREATMENTS PROVEN TO BE EFFECTIVE BY CONTROLLED TRIALS published in peer review journals 1. Laser Photocoagulation This treatment consists of a concentrated light beam of high energy, thermal light is directed on to the retina to destroy and seal the leaky blood vessels. A contact lens is placed onto the eye. The doctor will give you instructions on where to look, so that your eye remains still while the laser is focused on the area being treated at the back of the eye. The laser seals and destroys the blood vessel. This is not a painful procedure. The laser not only destroys the new vessel (CNV) but also destroys the area of retina involved with the new vessel. Therefore it can only be used for treating new vessels that are not under the centre of vision. This is only a small percentage of patients who present with wet MD. Close follow up and monitoring with the attending eye doctor is needed to determine if further treatment is required, as there is a 50% recurrence rate. Links to more information: http://www.amd.org/site/PageServer?pagename=Current_Treatments http://www.amdalliance.com/amd-info/personal/treatments/treatments.asp http://www.avclinic.com/treatment_options_for_armd.htm#Laser%20treatment http://www.allaboutvision.com/conditions/amd.htm 2. Photodynamic Therapy (PDT) / Visudyne Therapy This is a two step process combining a light sensitive drug (Visudyne) and the light from a non-thermal laser directed on to the retina. The chemical reaction between the laser and the drug causes the Choroidal New Vessels (CNV) blood vessel to close off. The 1 treatment does not cause direct damage to the surrounding retina. It therefore can be used to treat new vessels that are under the centre of vision. There are two types of new vessels (CNV) seen in wet MD. One is clearly delineated by fluorescein angiography and is called classic; the other is difficult to see clearly and is called occult or hidden. PDT is effective in the classic type of lesions regardless of size. PDT is also effective in small occult lesions but not large ones. PDT is a course of therapy and several treatments are needed to keep the leaking blood vessels closed and stop the progression of wet MD. Close follow up and monitoring with the attending eye doctor is needed to determine if further treatment is required. Links to more information: www.novartis.com.au http://www.amd.org/site/PageServer?pagename=Current_Treatments http://www.amdalliance.com/amd-info/personal/treatments/treatments.asp http://www.avclinic.com/photodynamic_therapy.htm www.visudyne.com (US website) http://www.novartis.com.au/consumer.html (search for ‘Visudyne’ from brand name list) http://www.allaboutvision.com/conditions/amd.htm 3. Macugen (pegaptanib) The blood vessels caused by Wet MD are prompted to grow by a protein called Vascular Endothelial Growth Factor (VEGF). Unfortunately this is not a good thing in MD as the new blood vessels damage the retina. This results in the loss of central vision. New drugs, called anti-VEGF drugs, are being developed to stop the growth of these blood vessels. Macugen is an anti-VEGF drug. It is injected into the eye (into the vitreous) at six week intervals. The vitreous is the jelly-like substance that fills the eyeball. Macugen has undergone phase 3 trials and has been shown to be as effective as PDT. However, similar to PDT, it has not been shown to be effective in either large occult or minimally classic lesions. There has been limited availability of Macugen under a special access scheme but this has now ceased for new patients. Links to more information: www.macugen.com (US website) http://www.amd.org/site/PageServer?pagename=Current_Treatments http://www.amdalliance.com/amd-info/personal/treatments/treatments.asp http://www.maculacenter.com/Procedures/Macugen.htm http://www.rxlist.com/cgi/generic4/macugen.htm http://www.osip.com/OSI/products.asp?id=186 http://www.multum.com/pegaptanib.htm http://www.vrmny.com/macugen.html http://www.revoptom.com/index.asp?ArticleType=SiteSpec&page=osc/3122/lesson.htm http://www.allaboutvision.com/conditions/amd.htm 4. Retaane (anecortave acetate) This drug is an angiostatic drug that inhibits the abnormal growth of blood vessels. Angiostatic cortisenes are derived from the steroid class and are made to remove chemical groups responsible for side effects, such as the development of cataracts and elevated intraocular pressure leading to glaucoma, while preserving potency against angiogenesis. 2 This drug is administered through a tube called a cannula that is inserted behind the eye. The drug is deposited at the back of the eyeball. It needs to be repeated every six months to maintain efficacy. The treatment appears to be as effective as PDT for lesions which contain some classic component. There are phase 3 trials being recruited looking at Retaane being used in conjunction with one of the anti-VEGF drugs. It has now been approved for use in Australia but no funding is available. The cost of the drug is $1800 and does not include the cost of the procedure. Links to more information: http://www.drugs.com/NDA/retaane_040630.html http://vision.about.com/od/maculardegeneration/a/retaane.htm http://www.docguide.com/news/content.nsf/news/8525697700573E18852570A50044E16 B http://www.amd.org/site/PageServer?pagename=RETAANEAustraliaApproval http://www.mdsupport.org/library/anti-angio.html http://www.mvrf.org/md101/newweapons.html http://www.allaboutvision.com/conditions/amd.htm TREATMENTS PROVEN TO BE EFFECTIVE BY CONTROLLED TRIALS but not yet published in peer review journals 1. Lucentis (ranibizumab) Lucentis is an anti-VEGF drug which is injected into the eye (into the vitreous) at 4 week intervals. The one year results have been reported and are soon to be published. The 2 year results are known and will soon be reported upon. They indicate that this treatment is dramatically more effective than any other treatment with 19 out of 20 patients maintaining vision and one in four improving. Lucentis is effective in maintaining or improving patients' vision dependent quality of life. Lucentis appears to be equally effective for all the types of wet MD and for all lesion sizes. This treatment is available under the TGA Authorized Prescriber or Special Access Scheme. Patients should discuss details of the injections with their doctor. Lucentis is currently in Phase 3 trials in Australia, looking at varying the frequency of administration and using it in combination with PDT. Links to more information: http://www.mdsupport.org/library/lucentis.html http://www.macular.org/news/lucentis.html http://www.amd.org/site/PageServer?pagename=Academy2005_Lucentis http://www.agingeye.net/mainnews/lucentis.php http://www.lighthouse.org/press/pr_genentech.htm http://www.medicalnewstoday.com/medicalnews.php?newsid=28005 http://www.seniorjournal.com/NEWS/Health/5-08-01LucentisHelpsAMD.htm http://vision.about.com/od/maculardegeneration/a/lucentis.htm http://www.revoptom.com/index.asp?ArticleType=SiteSpec&page=osc/3122/lesson.htm 3 EXPERIMENTAL TREATMENTS 1. Avastin (bevacizumab) Avastin is injected into the eye (into the vitreous) and is an Anti-VEGF drug like Lucentis. It was not designed for use in the eye and was produced and approved for the treatment of colorectal cancer. Use in the eye is therefore “off label”. There have been no controlled trials so there is no reliable information as to its efficacy or safety. It is not known how often it needs to be given. Currently, it is being used around the world including Australia over the last 6 months, for the treatment of wet MD because Lucentis is not available or may be too expensive. Reports of case series with limited follow up suggest it is effective in the short term. It does however require repeated injections. Links to more information: http://www.mdsupport.org/library/avastin.html http://www.allaboutvision.com/conditions/amd.htm http://www.avclinic.com/MacularDegeneration.htm http://www.webmd.com/content/article/81/96874.htm http://www.gordonresearch.com/answers/macular_degeneration.html 2. Triamcinalone (Kenacort) A slow release steroid designed for injection into joints, has been used "off label" by some retinal specialists to supplement CNV treatments particularly PDT. It seems to have a beneficial effect when used in conjunction with PDT but has been shown in a controlled trial to be ineffective as a sole treatment. It is injected into the eye but has been shown to promote cataract formation and in a third of patients to increase the intraocular pressure often necessitating glaucoma treatment. The effect of one injection lasts a few months. Side effects increase with repeated injections. 3. Evizon (squalamine lactate) Evison is given intravenously, eliminating the risk of infection and injury to the eye associated with intra vitreal injections. It is the first clinical drug candidate in a class of naturally occurring, pharmacologically active, small molecules known as amino sterols. It has a unique multi-faceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor (VEGF), cytoskeleton and integrin expression. It has not gone beyond phase 2 studies. There has been no explanation of the delay in starting phase 3 studies. Links to more information: http://www.genaera.com/squalamine.html http://www.agingeye.net/mainnews/EVIZON.php http://vision.about.com/od/maculardegeneration/a/evizon.htm http://www.pslgroup.com/dg/24ce46.htm Updated 7 July 2006 DISCLAIMER: The information contained in this fact sheet has been produced by the Macular Degeneration Foundation Ltd and is considered to be accurate at the time of publication. While every care has been taken in its preparation, medical advice should be sought from a doctor. The Macular Degeneration Foundation Ltd cannot be liable for any error or omission in this publication or for damages arising from its supply, performance or use, and makes no warranty of any kind, either expressed or implied in relation to this publication. 4