Putting eye health on the agenda for residential aged careNew digital training tools from Macular Disease Foundation Australia (MDFA) to improve understanding of eye health and vision loss in residential aged care facilities have been rolled out across Australia.

MDFA developed the training pack after it conducted a comprehensive study, which found high rates of eye disease, often under-diagnosed and untreated, in residential aged care facilities.

The resources include guidelines for management and healthcare professionals, as well as information for families and guardians. There’s also an easy-to-follow training video for aged care workers. (continued page 2)

Advocacy win on PBS

An additional 4,500 patients will be able to access subsidised medicine to treat macular disease, with a change to the Pharmaceutical Benefits Scheme (PBS) listing for two key medicines.

Macular Disease Foundation Australia said the federal Government’s decision to widen the number of macular conditions that can receive a subsidy for the drugs Dexamethasone (Ozurdex by Allergan) and Ranibizumab (Lucentis by Novartis) is a “big win for the macular disease community”.

“MDFA has been an active advocate for the additional PBS listings for these drugs,” CEO Dee Hopkins said.

“According to federal government figures, this listing will mean an additional 3,300 patients per year will be able to access Ozurdex and a further 1,200 patients a year will be able to access Lucentis.”

(continued page 10)

VisionVoiceSummer Edition 2018-19

1

Managing eye health and vision loss in residential aged care facilities

A resource for care workers on how to care for residents who are blind or have poor vision

Managing eye health and vision loss in

residential aged care facilities

A resource for management and

health professionals

1

Understanding eye health and vision loss

A resource for families / guardians of residents in aged care facilities

2 | Vision Voice Summer Edition | 3

Dee Hopkins Chief Executive Officer

CEO UpdateYou might recall from the last newsletter that MDFA has received funding from The Hon Greg Hunt, Minister for Health, to develop a National Action Plan for Macular Disease. The plan is in great shape and will be completed and handed to the Minister’s Office in December as promised.

In consultation with community members (those living with macular disease), the eye healthcare and medical profession, with allied eye health organisations, and industry, the key actions and recommendations of the report address the following pillars – prevention, treatment, support for people living with macular disease, research and data. I look forward to sharing the National Action Plan with you in early 2019, and I’d like to express my thanks to those members of our community who participated in focus groups and made a valuable contribution in representing the diverse range of needs in the macular disease community.

Another timely achievement has been the launch of the Vision and Eye Healthcare Study in Residential Aged Care Facilities report. The early feedback we have received from residential aged care facilities is that these resources will help them formulate policies and procedures to support those living with macular disease.

Finally, the MDFA team is working on new programs and systems to better support your needs, including a personalised patient care plan. I look forward to reporting back on this early in the new year.

As summer approaches, I encourage you to stay cool and hydrated. Summer is a good time to go enjoy the cool air conditioning in shopping malls and cinemas during the heat of the day!

On behalf of the board and staff, I wish you good health and happiness for the festive season.

Putting eye health on the agenda for residential aged care contd.

Talk Date Venue

Canberra 5 Feb Yowani Country Club

Shepparton 8 Feb Shepparton RSL

Parramatta 11 Feb Toongabbie Sports Club

Albury 13 Feb Albury Commercial Club

Bendigo 14 Feb Strathfieldsaye Community Church

Epping 18 Feb The Beecroft Club

Wonthaggi 19 Feb Wonthaggi Club

Mornington 20 Feb Mornington Golf Club

Leura 20 Feb Fairmont Resort Blue Mountains

Geelong 21 Feb Geelong RSL

Chatswood 23 Feb Northbridge Gold Club

Castle Hill 14 Mar Castle Hill RSL

Education SessionsMDFA delivers a range of practical information forums for people at risk or living with macular disease. Please book by phone: 1800 111 709 or email: info@mdfoundation.com.au

Myth: Wet (neovascular) AMD is the only eye condition that can be treated by anti-VEGF injections.

Fact: Anti-VEGF injections are also effective at treating other retinal conditions such as diabetic macular edema, retinal vein occlusion, myopic macular degeneration, and others which cause abnormal blood vessel growth and/or fluid leakage in/under the retina.

Myth: Anti-VEGF injections are painful.

Fact: Anti-VEGF injections are performed using a very fine needle. A small eyelid speculum is used to keep the eyelids open. To minimise discomfort, local anaesthetic is applied first to numb the eye. Antiseptic is used to prevent infection. Minimal discomfort is to be expected, but injections should not be painful.

Myth: One injection will cure my condition.

Fact: There is currently no cure, but treatment is highly effective. For most people, treatment usually begins with an initial course of three injections at monthly intervals. Repeated treatment is typically needed to maintain control of the condition. Depending on response to treatment, the interval between injections may be extended. This typically ranges from four to 12 weeks.

Myth: Anti-VEGF injections have no effect on vision.

Fact: Repeated anti-VEGF treatment helps stabilise and maintain best functional vision for as long as possible. The aim is to stop the growth of abnormal blood vessels and leakage of fluid under the retina. The earlier the treatment is commenced, the better the outcomes.

Our Helpline 1800 111 709 has more information on anti-VEGF injections.

Mythbusters: Anti-VEGF injections

MDFA CEO Dee Hopkins expressed the hope that these practical resources would be incorporated into management and staff training programs and embedded in practice.

The MDFA’s Vision and Eye Healthcare Study in Residential Aged Care Facilities report found more than 70% of residents who took part in the study had some form of eye disease; more than 60% had some degree of age-related macular degeneration and almost 30% had untreated cataracts.

“Vision loss in residents of aged care facilities can have so many negative consequences, such as increased risk of falls and fractures and a reduction in social independence. Vision loss also trebles the risk of depression,” Dee said.

“There’s a knowledge gap in residential aged care facilities, and that’s why MDFA has developed these practical educational resources focused on common eye disease, behavioural signs that may indicate loss of vision, where to go for more information and how to embed detection and treatment in aged care practices.”

The MDFA report and training resources have been sent electronically to thousands of residential aged care facilities across the country.

You can download them from the MDFA website www.mdfoundation.com.au or call the MDFA Helpline for assistance: 1800 111 709.

MDFA Annual General Meeting

Date: Tuesday, 4 December 2018

Time: 11.00am - 11.45am

Location: Art Gallery of NSW, Art Gallery Rd, The Domain, Sydney

The AGM will be held in the Centenary Auditorium. This will be followed by light refreshments at noon. There will also be an optional arts engagement program designed for individuals with low vision.

All welcome, but places are limited, so please call to confirm your attendance.

RSVP: 24 Nov on 1800 111 709

4 | Vision Voice

Westmead Institute for Medical Research examined data from more than 2,000 Australian adults over 15 years and found a particular flavonoid (powerful antioxidant) in oranges called hesperidin appears to help protect against the disease.

Researchers speculate that the beneficial impact of flavonoids on macular health comes from their antioxidant and anti-inflammatory properties. Further research is needed to validate the findings.

Another study from the same research institute has shown that eating 100 to 142mg of vegetable nitrates found in leafy green vegetables could help reduce the risk of developing early AMD by 35%.

The researchers analysed data on more than 2000 Australian adults over the age 49 who were followed over a period of 15 years. If confirmed in other studies, these findings could have positive implications for the prevention of AMD.

Flavonoids & Vegetable NitratesAn Australian study has shown that people who eat oranges daily have a 61% reduced risk of developing AMD than people who don’t eat oranges regularly.

Macular Disease Research UpdateDecember 2018

Spicy Festive Brazil Nuts

This Spicy Festive Brazil Nut recipe is irresistible when served warm, however it’s also a lovely homemade gift idea if presented in an airtight jar with a pretty label and ribbon.

You can use any mix of raw, unsalted nuts but I use Brazil nuts, which are high in selenium and especially good for macular health.

Other selenium-rich nuts are almonds, walnuts and pecans. Almonds, macadamias, walnuts and cashews are recommended for people with diabetes.

Ingredients

2 cups raw Brazil nuts

Spice mix: ½ tsp each of ground cumin, paprika, curry powder plus ¼ tsp each of sea salt, garlic powder, ground cayenne pepper, turmeric, ground ginger and cinnamon

2 tbs olive or peanut oil

Method

1. Heat oven to 160˚C (325˚F) Gas Mark 3 and line a small biscuit tray with baking paper.

2. Combine all the spices in a medium bowl; add oil and mix until smooth.

3. Put the nuts into the bowl and stir until they are evenly coated.

4. Spread evenly on the prepared pan in a single layer.

5. Bake nuts for 12-15 minutes, stirring at the halfway point.

6. Remove from oven and stir once more before letting cool slightly to serve.

7. Allow them to cool completely if putting into an airtight container.

Healthy Choices

Ita Buttrose AO OBEMDFA Patron

Clinical trials are studies in humans which aim to find a better way to manage a particular disease, while establishing correct dosage, safety and efficacy and comparisons to other treatments.

Trials are designed in a way to minimise the possibility of bias or incorrect conclusions.

Key:

Early studies with positive initial findings.

Studies with indication of a potential clinical effect.

Advanced studies with evidence of a significant clinical effect.

Early AMD

2RT laser

Results of the pivotal three-year clinical trial (LEAD trial) on the use of the ultrafast (nanosecond) laser called 2RT showed a promising trend in reducing the rate of progression to late stage AMD in carefully selected patients with earlier stages of the disease (large drusen). The 2RT laser uses ultra-short laser bursts to cause changes in the outer pigment layer of the retina, and slow down the degenerative process.

The trial found patients with less severe signs of AMD showed a nearly four-fold decrease in the progression rate of their disease, whereas patients with more severe signs at the beginning of the trial had a doubling of their progression rate to late stages of AMD when compared to patients who were not treated. It is the first time in more than 20 years of AMD laser research, that a laser intervention has successfully addressed disease progression.

Further studies need to be conducted and, at this stage, treatment with the 2RT laser should only be conducted within a clinical trial setting.

Dry (atrophic) AMD PRIMA

A new wireless bionic implant called PRIMA, designed for patients who have lost sight from late-stage dry AMD, has shown positive initial

findings in five patients. The device, developed by Pixium Vision, is surgically implanted under the atrophic macula and acts like a tiny solar panel powered by pulsed infrared light through a tiny projector that connects to a pair of glasses and mini-camera. All five patients were able to perceive light and identify several visual patterns such as bars, letters and numbers. Further overseas trials are expected. There are also plans to test PRIMA on patients with retinitis pigmentosa.

Complement inhibition

Overactivity of part of the body’s immune system, known as ‘complement’, has been shown to play a role in the development of AMD. A number of proteins are being developed to inhibit (block) different complement pathways in an attempt to reduce the development of dry AMD.

APL-2: An inhibitor targeting the complement protein C3 showed positive results in a phase 2 trial (FILLY). The treatment, given as an injection into the eye, was shown to reduce the progression of dry AMD by 29% over one year and the effect of the drug was greatest in the second six months of treatment. Two international, multi-centre phase 3 trials (OAKS & DERBY) have begun to assess the safety and efficacy of multiple injections of APL-2 into the eyes of patients with geographic atrophy.

Zimura: Another inhibitor, targeting the complement protein C5, is currently being investigated in an ongoing Phase 2b clinical trial for patients with geographic atrophy. A Phase 2b trial using the same drug began this year for patients with Stargardt disease, the most common form of childhood macular degeneration. Also, a phase 2a trial using Zimura in combination with anti-VEGF therapy (Lucentis) has begun for the treatment of wet (neovascular) AMD.

Wet (neovascular) AMD

Brolucizumab (RTH258)

Follow-up data from two large phase 3 (registration) trials (HAWK & HARRIER) for a newly developed anti-VEGF injection called Brolucizumab were recently announced.

Over a period of 48 weeks, both studies compared Brolucizumab with Eylea, an existing registered treatment. The safety of Brolucizumab compared favourably and more than 50% of patients on Brolucizumab were able to maintain 12-week intervals between injections until week 48, compared to the typical eight- week intervals for Eylea.

Follow-up data analysis showed retinal fluid, a key marker of disease in wet AMD, was detected less often in patients treated with Brolucizumab versus Eylea. As yet, there is no approval for the use of Brolucizumab in Australia. It’s expected that regulatory approval will be sought in due course.

Abicipar

Two phase 3 trials (SEQUOIA & CEDAR) evaluating the use of Abicipar for patients with wet AMD have shown encouraging results. The trials compared eight and 12 weekly dosing of Abicipar with monthly treatment with Lucentis. Allergan, the manufacturer, plans to file Abicipar with the FDA in 2019.

Port Delivery System

A new study shows a refillable drug implant the size of a grain of rice called the Port Delivery System can continuously deliver a concentrated version of Lucentis to patients with wet AMD over a longer period of time, compared to frequent injections of the same drug. The phase 2 trial (LADDER) exceeded expectations in terms of durability. Most participants maintained the full effect of the drug for six months or more without the need for a refill. A phase 3 trial (ARCHWAY) will begin this year.

PAN-90806

A phase 1/2 trial began in April to evaluate this once a day eye drop for the treatment of wet AMD and other eye conditions such as diabetic retinopathy, where abnormal blood vessels grow under the retina. Previous research showed that this drug was safe, tolerable and effective in suppressing the formation of new blood vessels. The overseas trial, expected to run until March 2019, will look at the use of the drug in patients across a higher and broader dose-range. The challenge will be delivering an adequate dose to the back of the eye.

OPT-302

Current injections for wet AMD block the protein VEGF-A. A new treatment in Australia called OPT-302 blocks two related proteins, VEGF-C and D, which are also thought to play a role in the formation of new blood vessels. A phase 1/2a trial using OPT-302 to target anti-VEGF-C/D with and without Lucentis to target anti-VEGF-A showed positive results of improving vision and retinal swelling. This suggests that combination therapy is a promising strategy to treat wet AMD and other retinal vascular diseases. Further phase 2 trials are currently being conducted.

Gene therapy: ADVM-022 A newly developed gene therapy for the treatment of wet AMD delivered as a single-injection into the eye showed positive results in laboratory studies. The therapy will now be tested in humans in a phase 1 clinical trial (OPTIC) in the US. Researchers believe ADVM-022 gene therapy has the potential to provide sustained VEGF inhibition thereby minimising the burden of frequent injections. The trial will run for two years.

Stem cell research

Two research groups, one in the UK and the other in the US, reported preliminary findings in early-phase clinical trials of stem cell-based treatments for AMD. The studies involved two different implants both designed to replace the retinal pigment epithelium (RPE), a cell layer that degenerates in patients with AMD.

The tiny implants consist of a single layer of up to 100,000 stem-cell derived RPE cells on an ultrathin synthetic membrane designed to mimic the membrane in the eye that supports the RPE.

The UK trial involved two patients with advanced wet AMD who were monitored for 12 months after receiving the implant and reported significant improvements in vision. The implants were well-tolerated, the cells remained stable and neither patient showed signs of rejection.

The US trial involved four patients with late-stage dry AMD who successfully received implants, which were also well-tolerated.

Summer Edition | 9

Technology & YouSmartphones have become the ‘Swiss Army knife’ of technology, providing a multi-purpose toolkit that integrates maps, calendar and time functions, camera-based object identification and support for a growing number of purpose-built apps for people with low vision. As a bonus, they even make phone calls!

MDFA looked at some useful (free) apps available for iPhones and Android via the App Store or Google Play.

ViaOpta Hello by NovartisDesigned to help low vision people with everyday life, the multi-award winning ViaOpta Hello app uses the smartphone camera to take pictures of objects or people – then provides a description. The app will even name people, if they’re in your contacts. The app was co-created with patient organisations. ViaOpta Hello is part of a suite of apps by Novartis for low vision users.

ViaOpta Daily provides multi-lingual support to identify text, maps, colours and objects and has a built-in magnifier while ViaOpta Nav provides voice-guided maps assistance specifically designed for low vision users.

A toolkit in your phone

Be My EyesBe My Eyes connects blind and low vision people with sighted volunteers for visual assistance through a live video call.

As a person with low vision, you use the app to communicate with a volunteer directly through your phone camera. The volunteer will guide you on what direction to point your camera so they can help with tasks such as reading labels, describing objects, helping you find a dropped item – even shopping or navigating unfamiliar surroundings.

More than 1.6m volunteers are available in 150 countries and 180 languages.

Medical ID: In case of emergencyIf you have an iPhone, chances are you already have this handy app, which comes standard within the pre-installed Health app. If you have an Android device, you can download it from Google Play.

Medical ID is easy to set up (open the Health app, select the Medical ID tab, then edit).

When ‘show when locked’ is selected, medical first responders can check critical health information even if your phone is locked (by selecting ‘Emergency – Medical ID’ on the lock screen). You can enter information about medications and health conditions – even who to call in an emergency.

The retina of each implanted patient showed structural changes consistent with the replacement of the RPE layer. None of the implanted eyes showed progression of vision loss, one eye showed improvement in vision and two eyes showed an improvement in visual fixation.

Further clinical trials are needed before stem cell therapy can be considered standard treatment.

Diabetic retinopathy: Emixustat hydrochloride An experimental oral medication for the treatment of proliferative diabetic retinopathy (DR) showed positive results in a phase 2 trial.

The results show the potential for the drug to decrease retinal thickness in patients with DR, and suggest the possibility of slowing the progression of DR. The manufacturer is pursuing research partnerships and preparing to launch further trials needed for regulatory approval.

Diabetic Macular Edema (DME)

Faricimab

Two phase 3 trials (YOSEMITE & RHINE) have started to evaluate the use of faricimab for the treatment of DME. Faricimab is a specialised antibody which inhibits both VEGF-A and Ang-2, proteins involved in the formation of new blood vessels (angiogenesis).

The drug is to be injected into the eye at eight-week intervals and compared with an injection of Eylea, also administered once every eight weeks. The trial is expected to run until mid-2022.

Faricimab is also being evaluated in a phase 2 trial (STAIRWAY) given either every 16 weeks or every 12 weeks to patients with wet AMD. Initial results show the potential for this drug to allow fewer injections while achieving the same results as current treatments. A phase 3 trial for faricimab in wet AMD is expected to begin in 2019.

Research Grants Program

To date, MDFA has committed $3.6 million to Australian research through its grants program.

Ten research projects are underway, and the next round of grants will open from 1 March 2019, for research commencing in 2020. Expressions of interest can be made via an online form, available on the MDFA website.

If you would like to donate to the MDFA Research Grants program call 1800 111 709 or donate online at www.mdfoundation.com.au

For further information and support, please call the MDFA Helpline on 1800 111 709.

Please note: Research is a lengthy, expensive and high-risk process. Some of these projects may not result in treatments, and others are years from completion. MDFA does not accept liability for out of date, misinterpreted or incorrect information.

This information is a summary only and further information on research or current clinical trials is available from MDFA on request. Discussion of a project does not constitute MDFA endorsement of that product or treatment.

10 | Vision Voice Summer Edition | 11

‘The Gracekeepers’by Kirsty Logan

The Gracekeepers follows the story of Callanish, a woman alone on her island. She has exiled herself to a life of tending watery graves as penance for a long-ago mistake that still haunts

her. Meanwhile, North works as a circus performer with the Excalibur, a floating troupe of acrobats, clowns, dancers, and trainers who sail from one archipelago to the next, entertaining in exchange for sustenance.

In a world divided between those inhabiting the mainland (“landlockers”) and those who float on the sea (“damplings”), loneliness has become a way of life for North and Callanish. A sudden storm brings change to both their lives – offering them a new understanding of the world they live in and the consequences of the past, while restoring hope in an unexpected future.

Inspired in part by Scottish myths and fairytales, The Gracekeepers tells a modern story of an irreparably changed world: one that harbours the same isolation and sadness, but also joys and marvels of our own age.

Book ClubAdvocacy & Representation

As the national peak body for macular disease, MDFA presented to the Medicare Benefits Schedule (MBS) Review Taskforce Ophthalmology Clinical Committee about the lack of equitable and accessible anti-VEGF treatment options across Australia, including wide variations in fees and the lack of public treatment options. MDFA also proposed that MBS rebates for Optical Coherence Tomography (OCT) be extended to cover monitoring of ongoing treatment.

MDFA has also made representations to the New Medical Research Future Fund 2018-2020 Priorities, about the lack of priority given to retinal diseases, including macular disease.

Advocacy win on PBS contd.

Your Voice

The cost savings on the medicine for these additional patients are significant. It is estimated the cost of Ozurdex will drop from $1,350 per script to $39.50, or $6.40 with a concession card. Similarly, without the PBS subsidy, Lucentis would cost a patient up to $7,000 over a year but will drop to $39.50 per script or $6.40 with concession.

Ozurdex and Lucentis are already used by ophthalmologists but the PBS subsidy was limited to selected conditions.

The expanded listing of Ozurdex means there’s another subsidised medicine for patients with reduced vision caused by macular swelling due to a blocked vein in the eye.

The expanded PBS listings for Lucentis mean that subsidised medicine is now available for macular conditions similar to wet AMD, where abnormal blood vessels grow under the macula, causing loss of central vision.

“These drugs have the potential to save sight, and in some cases improve vision,” Dee said.

“Putting them on the PBS for a greater number of macular conditions widens the net, which will allow more people than ever before to access subsidised medicine.”

Hoping a cure is on the cardsWhen people are shopping for hand-made greeting cards at Melbourne’s East Ringwood Market this holiday season, chances are they’ll also come home better informed about their macula.

And, whether they realise it or not, all the money they’ve handed over to 82-year-old Joan will make its way to the MDFA, to be used for research into macular disease. The cards are a labour of love, but also a way for Joan to raise money and awareness.

Over the past 15 years, age-related macular degeneration has stolen her sight and she’s had a big haemorrhage in her right eye this year, leaving her with a small amount of peripheral vision.

“I have always done craft. So now I listen to my audio books, and I make cards. I trim the cards up with a guillotine (and no, I don’t cut my fingers) but I couldn’t make the cards if I couldn’t blend the colours – I can still see colours.

“MDFA sends me leaflets. If people stand still long enough, I give them a leaflet. The taxi drivers get leaflets. I had some people knock on the door to tell me about the Bible; they left with leaflets.”

And when people buy her cards, she slips in a leaflet or Amsler grid as well. Joan directs MDFA to allocate all the money she raises to research, knowing the hereditary nature of the disease leaves her family – two children, eight grandchildren and three great-grandchildren – at risk.

“Research is important, and not just for my family. It is so, so important that people don’t end up like me.”

Joan dedicates hours to making cards and raising funds for MDFA.

Our Community

Give the Gift of SightGive your loved ones the gift of sight this Christmas by making a donation on their behalf to MDFA.

We will send them a lovely card to let them know of your generosity.

Call us on 1800 11 709 before 10 December to make sure they receive it in time for Christmas.

Thanks to Bolinda Publishing, we have three MP3 copies of The Gracekeepers to give away to the first three readers who contact MDFA on info@mdfoundation.com.au or 1800 111 709.

12 | Vision Voice

Contact Us: 1800 111 709 info@mdfoundation.com.au @maculardisease

@MacularDiseaseFoundationAustralia Suite 902, Level 9, 447 Kent Street, Sydney 2000

How we can support you

Disease information: Information on risk reduction, treatment, how best to manage macular disease and latest research.

Diet and Lifestyle: Advice on diet, lifestyle and supplements to support a healthy macula.

Low vision services: Advice on accessing low vision services, as well as instruction on low vision aids.

Transport options: Information and assistance on how to access transport services.

Connecting with the community: Assistance in connecting people with support in their local communities.

Translation services: Information in other languages, including interpreters for Helpline calls.

Navigating government support & subsidies: Assistance in navigating Medicare, NDIS, My Aged Care and carer support services, along with advice on rebates and treatment costs.

MDFA Helpline 1800 111 709