Welcome Clinical trials test new drugs, You do not always receive the to the latest so to a certain extent patients new drug, some people are edition of might think they are “guinea allocated the existing treatment MaculaNEWS pigs”, but in fact guinea pigs for comparison and you cannot in which we rarely benefit from the research choose which you get (neither will tell you that is done on them, whereas can we) but we make sure that more about patients often do. the comparison groups receive the Clinical the best possible treatment that Trials Unit of Studies have shown that is available so that it is unlikely the Macular Research Group. patients in clinical trials do that people who join one of our better than those who refuse studies will be worse off. In the past we have told you them even if they get placebo about the clinical trials that we (pretend treatment)! The good news is that clinical design and conduct ourselves, trials are free for participants. these are called “Investigator- Since all new drugs have to Initiated”. Now we would like be tested in large clinical trials I’d like to thank you for your to tell you about the trials we before they can be approved interest in our work, and conduct with support from for general use, participation encourage you to stay in touch. pharmaceutical companies, in a clinical trial is the only way known as “sponsored studies”. to receive a drug before it is Professor Mark Gillies and released. the Macular Research Group. Sponsored studies are usually conducted in conjunction with other clinics throughout the world. We receive funding to undertake these studies, but particularly with the Australian dollar as strong as it is we can barely cover costs.

Macular Telangiectasia (MacTel)

Idiopathic Juxtafoveal Macular and incompetent, like varicose As a leading centre in the Telangiectasia Type 2 (MacTel) veins. international MacTel Project, is an uncommon degenerative the Macular Research Group is While MacTel does not cause condition of the macula. hoping to commence a clinical total blindness, it commonly trial of a potential new treatment MacTel refers to a curious, causes slow loss of the central early next year sponsored by poorly understood condition vision, which is required for the Lowy Medical Research in which the blood vessels reading and driving vision, over Institute. around the central macula, or many years. fovea, which become dilated Age-Related

Advanced AMD alone results and destroy the degenerating with Lucentis for Wet Macular in up to 40,000 new cases of macula. Degeneration. blindness in Australia each year. Around 15% of people over 50 Wet AMD accounts for only 10% This 8-month trial sponsored by years of age (approximately of cases of AMD yet results in Allergan Pharmaceuticals will 750,000 Australians) have some 90% of the severe vision loss. establish whether the new drug early signs of AMD. lasts significantly longer so that It was discovered around 15 fewer injections are needed. The prevalence of AMD rises years ago that the protein with age, so that nearly two out “Vascular Endothelial Growth Dry AMD is proving a much of three people who reach the Factor” (VEGF) is the major tougher nut to crack than wet age of 90 will have early AMD, cause of bleeding and blood AMD, but this and other studies with one in four having loss of vessel leak in many macular that are planned will hopefully vision from late AMD. diseases. Wet AMD is now provide us with something that treated routinely with injections can slow the progress of dry Vision loss from advanced AMD of anti-VEGF drugs directly into AMD in future. is caused either by the “dry” the eye such as Lucentis and form, in which loss of vision due Avastin, often very successfully. The ideal treatment for dry to wasting of the degenerate AMD, retinal regeneration with macula is slow, or by a much REACH Study stem cells, is even optimistically more rapid and destructive The REACH Study, which is something like 10 years away. process called “wet” AMD, in currently enrolling patients, will which new blood vessels invade compare a new anti VEGF drug

Our aim: to develop new treatments that reduce blindness from macular disease, through multi-disciplinary and patient-oriented world-class research.

Branch Retinal Vein Occlusion

Clotting of blood in a retinal vein Branch Retinal Vein Occlusion The Brighter Study is a relatively common condition (BRVO) occurs when the Currently enrolling patients that is called Retinal Vein obstruction is in a “branch” with BRVO for treatment with Occlusion (RVO). retinal vein instead of the Lucentis, a VEGF inhibitor central retinal vein (see below). that has been used very When a retinal vein is blocked, successfully for wet AMD for blood returning from the If the occluded vein does not over six years. that is drained by the vein is drain the macula then the held up, causing the retina to patient may not even know it is This two year study has three bleed and swell, a condition there. If the macula is involved treatment arms. Lucentis known as retinal oedema. then blurred vision develops injections alone, laser alone, which cannot be cleared with or Lucentis injections in If the affected retinal vein drains glasses. Retinal vein occlusion combinations with laser. the macula, then this is another may improve without treatment cause of macular oedema that but most eyes are left with After six months patients may respond to treatments moderate loss of vision if not allocated to laser alone or that are also being tested for treated. injections alone will have the diabetic macular oedema. option of adding the second Diabetic Macular Oedema In the Pipeline Diabetic macular oedema ongoing but no longer accepting Clinical trials of (hopefully) (DMO), the commonest cause patients. This 3 year study is better treatments for these of loss of vision in people with comparing two different doses major vision-threatening , is caused by leaking of VEGF-Trap injections to laser macular diseases are starting retinal blood vessels with . VEGF-Trap is a new and finishing all the time in swelling of the central retina VEGF inhibitor, like Lucentis or our Clinical Research Unit. (macula). Avastin. VIVID will test whether VEGF-Trap lasts longer than As one of the major One in ten people with diabetes these established drugs. international centres for will suffer some loss of vision testing new treatments, the from DMO during their life. Study for a tablet treatment Macular Research group has for DMO participated in 32 major drug DMO traditionally has While injections into the eye been treated with laser company sponsored studies may be very effective, they over the last 10 years. photocoagulation, which seals must be given up to 4 weekly the leaking blood vessels in the and they also occasionally The intensive international macula, slowing the swelling cause side effects, some of clinical research activity, most that causes impaired vision. which may be serious. A tablet of which is sponsored by Laser may not improve vision that treated DMO effectively pharmaceutical companies, once it has become blurred but and more safely might be directed towards finding it can prevent it from worsening. attractive to many patients. better treatments for macular Such a drug, SB-480848 diseases has produced some We have recently started to which has been evaluated as outstanding results, such as treat DMO with injections into a treatment for hardening of Lucentis for wet AMD, over the eye as we do for macular the arteries (arteriosclerosis) is the last 10 years. degeneration. being tested in a 4 month study sponsored by GlaxoSmithKline Who knows where we will be The VIVID DME Study Pharmaceuticals. This study is in another 10 years? Sponsored by Bayer currently enrolling patients. Pharmaceuticals, this is

treatment (either injections or Our Macular Research Group were specifically made for use laser). pioneered the use of steroids inside the eye. This study will for macular oedema when we test whether the new drug lasts This study will establish how started testing “triamcinolone” even longer than Ozurdex, best to combine Lucentis with 10 years ago, however these which would mean fewer laser treatment. new drugs are safer since they injections for patients.

The BDP Study Central Retinal Vein Occlusion Ongoing but is no longer Central Retinal Vein Occlusion (CRVO) tends to be more severe enrolling patients. This one year than Branch Retinal Vein Occlusion (BRVO) since the entire retinal study sponsored by Allergan circulation is affected. AGN208397 was also available to people Pharmacuticals is comparing with CRVO through the BDP study. the effectiveness of injections into the eye of new steroid drug Currently we are offering patients with CRVO the chance to AGN208397 with an established participate in the Crystal Study, which is similar to the Brighter slow release steroid implant study except that all people receive Lucentis without any other “Ozurdex”. groups for comparison. Donations to Macular Research Group Contact the Macular Research Group at Save Sight Institute If you are in a position to help us continue our research please consider making a donation. You can contribute Laboratory team: online (www.savesightinstitute.com) or return this form to (02) 9382 7270 at GPO Box 4337, Sydney NSW 2001 or fax (02) 9382 7372. Clinical team: Please accept my gift of $ by : (02) 9382 7309 or 0412 338 075

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Printed: October 2012.