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• Sharpening focus on eye clinical trials

  News

  Sharpening focus on eye clinical trials

  On International Clinical Trials Day, we look back the origins of the clinical trial and focus on the future of eye research.

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  Clinical trials play a critical role in developing new treatments to prevent blindness, as innovative new technologies offer hope for people with previously untreatable eye diseases.

  But as cutting-edge technologies like gene therapy and artificial intelligence transform eye clinical trials – the fundamental principle of research has remained unchanged for more than 250 years.

  In 1747 Scottish naval doctor James Lind selected 12 men suffering from scurvy and divided them into six groups.

  He supplied each group a different suspected treatment for the disease, ranging from cider to sea water, and carefully observed their condition.

  The two men who were given oranges and lemons, both rich sources of vitamin C, improved so quickly they were able to nurse the others in the group.

  Lind’s basic design of a fair, comparative and controlled ‘like-for-like’ study is still the fundamental basis of all modern clinical trials, including those performed today at the Centre for Eye Research Australia.

  “Clinical trials are critical to collecting the evidence that is needed to prove new drugs and treatments work, and improve outcomes for patients,” says Head of CERA’s Clinical Trials Research Associate Professor Lyndell Lim.

  

  Clinical trial coordinator Bhaj Grewal assesses patients suitability for trials.

  Clinical trials at CERA

  Associate Professor Lim leads CERA’s Clinical Trial Research Centre which conducts trials for clinician-researchers, universities, pharmaceutical companies and biotech enterprises from around the world.

  Her team administers more than 30 trials annually for a broad range of eye diseases including age-related macular degeneration, diabetic eye disease, glaucoma and uveitis from its base at the Royal Victorian Eye and Ear Hospital in East Melbourne and a network of community clinics.

  Their work is complemented by an extensive clinical research program involving CERA’s Macular Research Unit led by Professor Robyn Guymer AM and a fast-emerging retinal gene therapy research program led by Dr Tom Edwards.

  Last year CERA’s retinal gene therapy researchers joined forces to with colleagues from the Eye and Eye Hospital to deliver  Australia’s first investigational gene therapy  for dry age-related macular degeneration.

  They were also a part of another global study investigating the use of an anti-oxidant as a potential treatment to prevent vision loss from retinitis pigmentosa in people with Usher Syndrome.

  

  Senior Clinical Trials Manager at CTRC Marios Constantinou examines a patient’s eye.

  Identifying participants

  Identifying suitable people to take part in research is an important factor in running a successful clinical trial.

  CERA’s close partnerships with the Eye and Ear Hospital, private ophthalmologists and a growing network of optometrists provides a rich source of participants.

  Two large natural history studies – of people with age-related macular degeneration and inherited retinal diseases – have enabled CERA to link people with these conditions to suitable trials when new potential treatments emerge.

  In the case of people with conditions like ‘dry’ age-related macular degeneration and inherited retinal diseases, for which there are currently no approved treatments, taking part in a trial offers access to potentially sight-saving treatments.

  Successful clinical research also relies on understanding what matters to patients and their families –  as well as ensuring that they are well informed about the role of research.

  Understanding what matters to trial participants and their families, as well as ensuring they are well informed about the role of research is also critical to a successful trial.

  CERA and the University of Melbourne conducted a world-first survey which asked patients with inherited retinal diseases about their views on potential gene therapies. These findings will provide a valuable resource for future trials.

  

  Dr Tom Edwards performing Australia’s first investigational gene therapy for dry AMD.

  Screening process

  When a person is being considered to take part in a clinical trial they must first undergo a thorough screening to assess their suitability, as well has have a thorough discussion with study doctors and coordinators to understand how the trial will operate.

  Suitable patients are then assigned to a treatment group.

  Clinical trials typically compare a new treatment to standard current treatments, although if there is no current treatment it is compared to a placebo, or ‘pretend’, treatment.

  To make sure the results are fair, patients are randomly assigned to treatment groups, and both study participants and doctors do not necessarily know who is in each group.

  Changing lives

  CERA Managing Director Professor Keith Martin, who has been an ophthalmologist and vision researcher for more than 25 years says there has never been a more exciting time in eye research – for patients, clinicians and scientists.

  “Less than a decade ago, someone with an inherited retinal disease (IRD), or a condition like dry age macular degeneration or even glaucoma that is not responding to the conventional treatments, would be told there was nothing that could be done for their condition.

  “But now gene therapies are offering real prospects of saving – and even restoring sight.’’

  Just like Lind’s original research into scurvy, the ongoing to work of clinical trials is crucial to bringing life-changing treatments to people.

  Take part in research

  If you are interested in taking part in a clinical trial at CERA visit our Take Part in Research page for more information and to register your interest.

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  Clinical Trials

  Take part in research

  CERA is an international leader in eye research. Our world-class knowledge and expertise are used to discover better treatments, deliver faster diagnoses, and prevent eye disease.

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  Science and research

  Clinical trials research

  CERA conducts leading clinical trials across a variety of eye conditions, including diabetic eye disease, age-related macular degeneration, glaucoma, uveitis, inherited retinal diseases as well as other less common eye diseases.

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• Helping find the missing puzzle piece through macular research

  STORIES

  Helping find the missing puzzle piece through macular research

  Finding the missing piece of the age-related macular degeneration (AMD) puzzle could be the difference between vision loss and reconnecting people like Jim with the world they once saw so clearly.

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  The first time you meet Jim, you just know you’re going to like him. He’s the sort of person that lends a hand whenever possible and tackles challenges or problems head on and with a positive attitude.

  Retired now, Jim and wife Clare love being a part of their three married daughters’ lives and the chaotic fun of eight grandchildren.

  “They’re wonderful and they keep us very, very busy,” Jim said laughing.

  Between 2005 and 2019, Jim and Clare’s love of travel took them all over the world from Japan to Croatia and from the Mediterranean to Alaska. Unfortunately, as the world opens up again, future travel is off the cards.

  “We won’t travel anymore. Not because we don’t want to but because of my eyesight,” said Jim. “There’s just no point, I can’t see as much as I used to, and it’s difficult.”

  Jim has advanced dry age-related macular degeneration (AMD).

  This can be a devastating diagnosis as there are still no effective treatments for dry AMD.

  While the treatment of wet AMD has significantly improved the lives of those living with it, dry AMD leads to a gradual and permanent loss of central vision.

  When we recently spoke with Jim and asked how his sight was, he replied, “Well, it’s impossible to read and I can’t see photographs anymore. I’m also experiencing double vision, so I know it’s getting worse. But you can’t stop can you? You’ve just got to get on with it.”

  

  Jim took part in a CERA trial investigating a potential new treatment for dry AMD.

  AMD research

  Finding the missing piece of the age-related macular degeneration (AMD) puzzle could be the difference between vision loss and re-connecting people like Jim with the world they once saw so clearly.

  As Head of CERA’s Macular Research Unit, Professor Robyn Guymer AM is always urging the team to ask key research questions that will help bring all the AMD puzzle pieces together.

  How do we predict, among all the people who have wet or dry AMD, who is at high-risk of progression? Can we slow down the progression of AMD? And how do we optimise outcomes in wet AMD to minimise repeat treatments?

  In the CERA labs, we have teams investigating the genetic causes of AMD, developing new therapies to treat retinal diseases, and looking at new ways to deliver AMD treatments so that in the future people will need fewer injections or be able to take eye drops instead.

  Our teams are also working with eye clinics in suburban areas so there is greater access for people unable to come to Melbourne.

  

  Professor Robyn Guymer and CERA’s Macular Research team are hoping to create a brighter future for people like Jim.

  Hope for future generations

  Jim took part in a clinical trial at CERA, one of nearly 20 clinical research projects currently being undertaken, with more participants actively being sought for future AMD trials.

  “The Macular Team called to explain the clinical trial to see if I was suitable to be fitted with a device that could increase the blood flow to the back of my eye, potentially offering a new effective treatment for dry AMD and I signed up straight away.

  “Unfortunately, I didn’t qualify, but just knowing that there is potentially a life-changing operation available for people like me who thought this would never be possible, it’s amazing.

  “The researchers involved, and what they’re working on might not help me. But it might help my grandkids and other people that have similar problems. If I can be part of helping to find a solution, I’m proud to have been involved.”

  Tax Appeal 2022

  Help our researchers make breakthroughs that will transform our understanding and treatment of AMD – and give people like Jim more moments with the ones they love.

  You can make a donation online or call 1300 737 757.

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  25 years of macular research at CERA

  CERA’s Macular Research Unit is celebrating 25 years of research, clinical trials and achievements.

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  Our research program

  The Synergy High Risk Age-related Macular Degeneration (AMD) Study is led by CERA in partnership with the University of Melbourne, the Walter and Eliza Hall Institute of Medical Research and international collaborators.

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• Understanding female IRD carriers

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  Understanding female IRD carriers

  Research into X-linked inherited retinal diseases often focuses on males, but a study at CERA is aiming to make sure everyone benefits from newly developed treatments.

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  Inherited retinal diseases (IRD), a broad group of genetic eye conditions caused by changes in a person’s genetic code, do not always affect men and women in the same way.

  “A majority of female carriers of X-linked IRDs have a near-normal retina, while at the other end of the spectrum is quite severe disease, similar to what males with these conditions experience,” says Sena Gocuk, optometrist, CERA researcher and PhD candidate at the University of Melbourne.

  The condition of many female carriers can often be so mild that it is only identified after a male relative is diagnosed with an inherited disorder.

  This lesser severity has led past research to focus only on males with these diseases, but a new study at CERA is seeking help change that.

  Operating instructions

  Chromosomes, the thread-like structures located inside the nucleus of living cells, contain the instructions for how those cells should operate.

  They also determine a person’s biological sex; females have two X-chromosomes and males have one X-chromosome and one Y-chromosome.

  For IRDs caused by changes in the DNA code of eye genes found on the X-chromosome, the sexes can be affected in very different ways.

  “Conditions like choroideremia, and some forms of retinitis pigmentosa, are X-linked conditions, meaning they are caused by faults in the X-chromosome,” says Gocuk.

  “For males, who only have one X-chromosome, a single copy of the mutated gene means that they will develop the retinal condition.”

  For females, who have two X-chromosomes, an X-linked retinal condition may present quite differently – with some women having no symptoms, and others noting changes in their vision.

  “If a female has one mutated and one normal gene, individual cells decide which of the two X-chromosomes are expressed,” says Gocuk.

  “Because of that, you get a wide spectrum of disease severities.”

  

  Participants will receive genetic testing and a comprehensive eye examination.

  Survey and study

  The study involves clinical visits, where Gocuk will learn more about the eye health of female carriers of these X-linked retinal diseases.

  Participants will receive genetic testing and counselling, undergo a comprehensive eye examination to assess their retinae, and also have the opportunity to continue in the study to monitor how their vision changes over time.

  In another part of her study, Gocuk is asking mothers, sisters and daughters of males with X-linked IRDs to complete an online survey, in order to develop a better understanding of how the condition affects women, and also their opinion of whether future gene therapies might potentially benefit them.

  “Questionnaires that have looked at female carriers of other genetic conditions have found a lot of women experience shock, guilt and anxiety when their male relatives are diagnosed,” says Gocuk.

  “One of my participants became quite teary when speaking with me about her experiences, because she has a number of male relatives with retinitis.

  “She knows that this research might not benefit her or her children, but she wants to contribute.

  “It’s been quite rewarding to hear these stories.”

  Gocuk is a recipient of the University of Melbourne’s Harold Mitchell Postgraduate Travelling Fellowship, and will use the funds to travel to the University of Oxford to examine 10-year data from a UK longitudinal study as part of the project.

  Her work is also running alongside another ongoing study at CERA, surveying people who are living with an IRD.

  Gocuk says she hopes her research might help lay the groundwork to see whether more people can benefit from emerging genetic treatments.

  “I would be pleased if we were able to determine if some of these women would be eligible for emerging treatments, like gene therapy.

  “It would be quite rewarding, and potentially life changing for this group of people.”

  If you think you’re a female carrier of an X-linked inherited retinal disease or would like further information, please email Sena Gocuk: sena.gocuk@unimelb.edu.au.

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  New survey explores genetic testing and inherited retinal disease

  People living with an inherited eye disease who have received genetic testing are invited to participate in a national survey led by the Centre for Eye Research Australia and the University of Melbourne.

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  Register your interest in clinical trials

  To express interest in taking part in current or future clinical trials at CERA, please join our online database.

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• 25 years of macular research at CERA

  STORIES

  Helping find the missing puzzle piece through macular research

  Finding the missing piece of the age-related macular degeneration (AMD) puzzle could be the difference between vision loss and reconnecting people like Jim with the world they once saw so clearly.

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  A quarter of a century ago people diagnosed with age-related macular degeneration (AMD) did not have much hope their vision could be saved.

  Treatments for the condition were virtually non-existent, and the outcome for most patients would be either a sudden loss of vision, or a more a gradual, irreversible loss of sight.

  It was in these circumstances that CERA’s Deputy Director and Head of Macular Research Professor Robyn Guymer AM established CERA’s Macular Research Unit (MRU).

  In the 25 years that have followed, the team has counted many significant achievements towards both understanding and treating AMD.

  Though there is still lots of work to be done, the collective efforts of everyone who has ever been a part of the MRU have helped make the prognosis nowhere near as bleak as it once was.

  

  Professor Robyn Guymer and research nurse Melinda Cain have been part of the Macular Research Unit for 25 years.

  Early days

  After completing a fellowship at Moorfields Eye Hospital in London, Professor Guymer came home to Melbourne to establish the Macular Research Unit at CERA in 1997.

  At the time very little was understood about the condition.

  “We had only just realised macular degeneration was an inherited disease, but we did not yet know of any genes associated with it,” says Professor Guymer.

  “And so, the research approach at the time was to find diseases that looked like AMD, try and find the genes associated with those diseases, and hope that they had a connection with AMD.”

  Finding these genes was the first aim.

  “If you find the gene, you find the pathway, and then you can look for treatments,” says Professor Guymer.

  “To do that, we needed to find families with AMD as well as other families with rare inherited retinal diseases so that we could study them one by one.”

  With an initial grant of $10,000 for a portable retinal camera, Professor Guymer and her only other unit member, research nurse Melinda Cain – who is still with the unit today – spent several years travelling through regional Victoria and Tasmania taking blood samples and photos of the eyes of families with suspected AMD.

  Remarkably, they found a family of 20 siblings many of whom had a rare, devastating, dominantly inherited retinal condition similar to AMD called Malattia Leventinese.

  “Because of this large family, as well as others, we were able to help our collaborators narrow the region of interest on the chromosome carrying the gene so that they could find the gene that caused Malattia Leventinese,” says Professor Guymer.

  Their work created leads towards the mechanisms that cause retinal diseases and helped establish the MRU as a group that could contribute well-classified clinical cases for ongoing genetic analysis.

  Twenty-five years later, the the unit is still contributing to this ongoing work as part of large genetic consortia.

  

  Professor Robyn Guymer with Dr Zhichao Wu, who now leads CERA’s Clinical Biomarkers team.

  Improved imaging

  Alongside an increasing understanding of the causes of AMD, the ability to take an image of the retina has also come a long way.

  In the late 1990s, just as Professor Guymer was finishing up her time at Moorfield’s Eye Hospital in the UK, the first Optical Coherence Tomography (OCT) imaging devices were becoming clinically available.

  OCT devices capture a cross-section image of the retina in a living eye, showing each of the retina’s distinctive layers.

  Dr Zhichao Wu, as part of his PhD from 2012-2014, used this advanced imaging technique to follow people as they progressed through AMD.

  “As part of his spectacular PhD, we announced to the world the specific changes you could see along the way that we felt were evidence of cell death, or the first sign of atrophy,” says Professor Guymer.

  “We coined this term nascent geographic atrophy n(GA), geographic atrophy, or GA, as the term used for the late dry form of AMD where there are large areas of atrophy.”

  Identifying and monitoring early signs of disease is an important part of the efforts to intervene in AMD before there is significant loss of retinal cells.

  Dr Wu continues on at CERA, now leading his own unit to further work on early markers of disease progression in both AMD and glaucoma.

  Vision in the dark

  Also important is understanding what facets of visual function are affected early in AMD.

  This is challenging during the earliest stages of AMD –  the traditional measure of visual function is visual acuity and it is generally normal.

  But what is known, and is a common complaint among patients, is that seeing in the dark becomes difficult.

  Measuring a person’s ability see in the dark has been an interest of Associate Professor Chi Luu, who initially spent time in MRU working on one of Professor Guymer’s interventional studies in the late 1990’s whilst a PhD student, then later returned to join the unit to work on the bionic eye project in 2008.

  In AMD, however, he has worked on improving the ability of researchers to be able to measure the ability of the eye to adapt to the dark.

  Though a grant Professor Guymer received from the US-based Beckman Initiative in AMD (now Ryan initiative), A/Prof Luu helped design a new device capable of measuring night vision with the Australian company Medmont.

  “The DACP field machine allowed many areas of the retina to be tested in one sitting, which was not possible with the device used at the time, allowing a much better idea of the regional health of the macula to be assessed,” says Professor Guymer.

  “We are internationally known as a leader in understanding how to measure and interpret the eyes’ ability to adjust and see in the dark, which is a very sensitive way of picking up early defects in AMD.”

  The DACP machine is now in use by many research groups worldwide.

  

  Associate Professor Lyndell Lim performed the first intravitreal injection for AMD at the Royal Victorian Eye and Ear Hospital.

  Clinical trials

  Associate Professor Lyndell Lim, who is now head of the Clinical Trials Research Centre (CTRC) at CERA, was the macular team’s first retinal research fellow in 2003.

  She performed the first intravitreal injection for AMD at the Royal Victorian Eye and Ear Hospital, trialling a medication designed to treat the late wet stage of AMD.

  “Up until then people had not injected an eye on an ongoing, multi-year basis, so no-one knew how the eye would cope,” says Professor Guymer.

  CERA has since been invited to take part in many of the major international clinical trials for wet AMD, and now dry AMD, treatments, and this clinical trial activity has become too great for one set of researchers.

  To support the growing number of clinical trials, A/Prof Lim went on to establish CERA’s clinical trial research unit to manage not only the large industry trials for AMD, but many of the other diseases being investigated by CERA.

  

  Golda Hough is a participant in an AMD trial at CERA.

  Reticular pseudodrusen

  Between 2012 and 2018 Professor Guymer and her team designed and led the LEAD study.

  It was the first randomised clinical trial investigating the possibility that a nanosecond laser, developed by the Australian laser company Ellex  (now NovaEye) may slow the progression of intermediate stage AMD.

  “Whilst we continue pursuing subthreshold short pulse laser as a possible intervention, the LEAD trial confirmed in our minds the need to concentrate on people with unusual deposits called reticular pseudodrusen, as these people had a sub optimal response to the laser compared to those without RPD,” says Professor Guymer.

  “Our interest now is to try to find a genetic association with that particular phenotype because, I think, this will lead us to better understand the mechanisms underlying the development of  reticular pseudodrusen and why some people have more profound vision loss in AMD.”

  Professor Guymer and her team now lead, with support from the National Health and Medical Research Council, an international consortium further investigating the impact of reticular pseudodrusen.

   

  Tax Appeal 2022

  Much has been achieved in the last 25 years in macular research, but there is still plenty to do for the next quarter decade.

  To help our researchers make breakthroughs that will transform our understanding and treatment of AMD, you can make a donation online or call 1300 737 757.

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  News

  25 years of macular research at CERA

  CERA’s Macular Research Unit is celebrating 25 years of research, clinical trials and achievements.

  Read More

  Synergy High Risk AMD Study

  Our research program

  The Synergy High Risk Age-related Macular Degeneration (AMD) Study is led by CERA in partnership with the University of Melbourne, the Walter and Eliza Hall Institute of Medical Research and international collaborators.

  Read More

• Meet our researchers: Dr Michelle Waugh

  News

  Meet our researchers: Dr Michelle Waugh

  Dr Michelle Waugh is a Research Fellow in CERA’s Health Services Research Unit. She is investigating the potential impacts of the implementation of digital technologies in health services.

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  What has your experience been before you came to be a researcher at CERA?

  I studied optometry followed by a PhD with Professor Erica Fletcher at the University of Melbourne.

  My PhD was a lab-based project investigating immune responses that impact the activity of microglia (a type of cell located throughout the central nervous system), and how this activity contributes to retinal degeneration.

  At the time I joined CERA I was looking for a new challenge and had been involved in Melbourne University’s Biodesign Innovation program.

  Under this program I was already looking at the way health services work within private and public hospitals with respect to how new medical device technologies are evaluated and integrated into existing services.

  When I met Peter Larsen (Honorary Principal Investigator of CERA’s Health Services Research Unit), I found that so many of the ideas we discussed really aligned with my interests, especially the potential to ‘open the lid’ on generating and using data for continuous improvement in health systems.

   

  What is the most innovative part of your research in health services?

  Our research investigates the impact of digital health on health services and how it can help shape service improvement.

  Since a lot of digital health tools have not yet had a chance to be integrated into the public health arena, this area has a lot of innovative potential.

  There are always going to be challenges integrating new systems and technologies within public health systems. There are always risks that need to be managed with bringing in new processes into complicated systems like hospitals.

  There is an exciting opportunity for researchers to work with hospitals to help with the process of integrating new technologies into their systems.

  Ultimately, it is a collaborative effort: research can help inform health services improvement, and together we can work on projects that will have beneficial outcomes for patients in the future.

  

  Dr Michelle Waugh is investigating the potential impacts of the implementation of digital technologies in health services.

  What do you think are the benefits of being a clinician-researcher?

  The core of our research is aiming to improve existing services.

  My experience as a clinician allows me to understand the clinical aspects of the conditions being treated in these services, and the practical aspects of how the systems work and why they work that way.

  For example, a medical retina triage service and a glaucoma triage service are run differently because the conditions and data evaluated for the purposes of triaging are different in nature.

  Without being a clinician, it might be more difficult to understand why the systems operate the way they do.

   

  Why do you think it’s important to conduct research into improving eyecare services?

  Research to improve eyecare services has the potential to not only improve care for patients but also help clinicians be more effective, and so it’s a really important research area.

  Also, there is a lot more focus on translational research these days: applying practical solutions that can positively impact patients directly.

  Additionally, it’s mutually beneficial for health services and research institutions to work together and enable cross-pollination of knowledge that will benefit both clinicians and researchers.

  Ultimately, these collective efforts will lead to better outcomes for patients.

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• Glaucoma vitamin B3 trial

  Research

  Glaucoma vitamin B3 trial

  Research to determine if vitamin B3 can treat optic nerve damage caused by glaucoma is set to move into a new phase.

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  Most therapies for glaucoma aim to reduce eye pressure to prevent nerve cell damage and vision loss.

  CERA researchers are investigating a form of vitamin B3 that could help existing treatments prevent the disease’s progression.

  If demonstrated to be effective, the simple daily tablet would be the first treatment that specifically targets nerve cells in glaucoma.

  CERA Glaucoma Research Fellow Dr Flora Hui led a world-first clinical trial on high-dose nicotinamide (vitamin B3) that found it could lead to improvement in visual function.

  Published in Clinical & Experimental Ophthalmology in 2020, the study showed improvement in the visual function of glaucoma patients who took a high dose of nicotinamide daily for 12 weeks on top of their regular treatment to reduce eye pressure.

  Investigating impact

  Dr Hui is now co-principal investigator of a larger trial set to start in 2022 after securing a $200,000 Glaucoma Australia Quinlivan Research Grant.

  Participants with three common types of glaucoma will take vitamin B3 daily for two years and have the progression of their glaucoma monitored every four months.

  At the same time, Assistant Professor Pete Williams from Sweden’s Karolinska Institutet will conduct a similar trial there. Other collaborators include CERA Managing Director Professor Keith Martin, Professor Jonathan Crowston from Duke NUS-Medical School in Singapore, and Professor Robert Casson from the University of Adelaide.

  Supplementing treatments

  If the new trial is successful, vitamin B3 could become part of a holistic glaucoma treatment plan.

  The idea grew from previous research into mitochondria, which give cells the energy they need to function. If this supply is interrupted, the nerve cells, in this case at the back of the eye, can lose function.

  Vitamin B3 had been shown to improve function in other cells and is now showing promise in the eye. The dose is higher than that found in food sources but is easily sourced in a tablet.

  “All the current glaucoma therapies target eye pressure and reducing eye pressure,” Dr Hui says. “We do know that despite current treatments, some people continue to progress and lose vision.

  “The idea with vitamin B3 is to try and supplement the nerve cells at the back of the eye and help them to function better. This can help reduce further vision loss.”

  If successful, the trial could translate into a new treatment relatively quickly as nicotinamide is already available.

  “If we find that it’s useful in glaucoma … once we get the news out doctors can start giving it to their patients almost immediately,” Dr Hui says.

  “It’s really exciting because it’s what you want to do in research – you want to make a difference.”

  

  Professor Keith Martin is also part of the vitamin B3 trial.

  Participant Q&A

  How do I qualify for the trial?

  You must be aged 18 and over and have primary open angle, normal tension or pseudoexfoliative glaucoma.

  How do I join?

  The best way is to join the CERA trial registry, which notifies you of trials that may be suitable.

  How long will it take?

  Participants will take vitamin B3 and have their health monitored every four months over two years. Check-ups will take place in Melbourne and Adelaide.

  How will my progress be monitored?

  Every four months participants will visit a clinic in Melbourne or Adelaide for an eye check-up. It is similar to a regular glaucoma check, with a few extra aspects and an optional blood test for genetics analysis.

  What happens when it’s over?

  Researchers will collate the results to see if vitamin B3 used in conjunction with conventional therapies has helped to stem the progress of glaucoma-related vision loss. If so, doctors may start recommending it as part of an overall treatment plan.

  * Earlier stages of this research were supported by the Jean Miller Foundation, Connie and Craig Kimberley Foundation, Ophthalmic Research Institute of Australia, Jack Brockhoff Foundation, Marian and EH Flack Trust, Fund and Board of Research Faculty Karolinska Institutet.

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  Clinical trials

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• Meet our researchers: Dr Elsa Chan

  News

  Meet our researchers: Dr Michelle Waugh

  Dr Michelle Waugh is a Research Fellow in CERA’s Health Services Research Unit. She is investigating the potential impacts of the implementation of digital technologies in health services.

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  What drew you to a career in research?

  I completed my PhD at the Department of Pharmacology, University of Melbourne, and my main motivation to pursue research was to find a cure for diseases.

  I also liked the flexibility of research and being able to balance my time and invest in doing the things I was interested in, rather than the regular 9 to 5 job. When I was doing my post-doc, it was also exciting to travel to conferences and exchange ideas with researchers around the world.

  What motivated you to follow vision research after originally starting in the cardiovascular area?

  I was working with Professor Greg Dusting who also initially worked in cardiovascular research, and so when he started working with CERA we all changed our focus to look at similar mechanisms in the eye.

  Now I work closely with several different researchers at CERA, particularly with Dr Jennifer Fan Gaskin, investigating ways to improve surgical outcomes after eye surgery and manage complications that can arise. It’s really rewarding to think our work can help achieve better treatments for patients.

  What is the most interesting discovery you’ve made while researching ocular inflammation and scarring?

  If we go back to my PhD, during my studies I was investigating a family of compounds called flavonoids. Flavonoids are found in a lot of fruits and vegetables, and because there is a lot of evidence suggesting that a healthy diet is good for heart disease, we wanted to investigate if flavonoids offer any protective effects, and we discovered that they do.

  Later when we joined CERA, we revisited that work to see if the same compounds had any protective effects for ocular inflammation and fibrosis, and again we found that they do!

  

  Investigating ways to improve surgical outcomes: Dr Chan (centre) with Dr Shah (left) and Dr Fan Gaskin (right).

  Why are translation projects important for research?

  There are many great things that my team and other groups at CERA are working on in the lab that we hope will eventually turn into therapies for people to use, and that’s why commercialisation is so important. But if we want to translate research we need to have preclinical and clinical studies.

  Recently, we’ve been working with CERA Board Director Professor Darren Kelly who has a lot of experience in commercialisation and an understanding of taking compounds from “bench to bedside.” Although the road to commercialisation can be long, it’s absolutely crucial if we want our research to make a real-life impact.

  How would you like to see your research translate into clinical therapies?

  I think I would like to see our research improve current surgery and therapy methods. For example, there are complications that can occur from scarring in the eye following glaucoma surgery. The current treatment for controlling scarring is cytotoxic, but it is the only method we have that works. We would like to completely replace that treatment with something new and non-cytotoxic.

  We will continue to use experimental models to test therapies in the lab, and then hopefully secure funding to perfect those therapies for surgeons to use in order to improve outcomes for patients.

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• World Optometry Day 2022

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  World Optometry Day 2022

  Today on World Optometry Day, CERA is recognising the crucial role optometrists play in both modern healthcare and ongoing research.

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  Since the first pair of spectacles were made in northern Italy during the late 13^th century, optometry has developed into a crucial component of the world’s healthcare system.

  Continuing the profession’s evolution over the last 700 years, new technology and treatments being developed at CERA are aiming to allow optometrists to diagnose conditions earlier than ever before in order to save people’s sight.

  World Optometry Day is just one moment to acknowledge the profession’s contribution to the healthcare systems, individual’s overall health and many ongoing research efforts.

  

  Associate Professor Lauren Ayton says it is currently an exciting time for clinician researchers

  Earlier diagnosis

  Associate Professor Lauren Ayton, who completed her professional training in optometry prior to her PhD and career in research, says optometrists play a crucial role in early detection of eye disease.

  “Many blinding eye diseases are asymptomatic in the early stages,” A/Prof Ayton says.

  “Hence, conditions like glaucoma and age-related macular degeneration are often first detected in people presenting for a routine eye examination with their optometrist.

  “It is important that optometrists are aware of the latest advances in diagnosis and management of these conditions, so that they can refer or manage appropriately.”

  Given this role that optometrists play, it is unsurprising that optometrists are playing crucial roles across several of CERA’s ongoing research projects.

  Dr Zhichao Wu, Head of Clinical Biomarkers Research at CERA and optometrist, is using artificial intelligence alongside cutting-edge imaging to accelerate the discovery of new signs of age-related macular degeneration (AMD) and glaucoma.

  Leading CERA’s Keratoconus International Consortium, optometrist and research scientist Dr Srujana Sahebjada is using similar techniques to detect and monitor corneal disease.

  Optometrist Carla Abbott, a clinician scientist and research fellow working with CERA Deputy Director Professor Robyn Guymer’s Macular Research unit, is playing a critical role in CERA’s research into both the significance of reticular pseudodrusen in AMD and the bionic eye project.

  And Research Fellow and optometrist Dr Flora Hui is leading a trial to determine whether Vitamin B3 has the potential to lead to improvements in vision among glaucoma patients.

  Taking a broader perspective is CERA’s Health Services Unit, led by Peter Larsen, is examining how communication can improve communication and coordination across both optometry and the entire health services sector.

  Crucial communication

  Optometrists are also a source of patient education about eye disease, placing them in a crucial role in communicating with the community.

  Ongoing projects at CERA working to make this communication even better.

  Led by optometrists Dr Ceecee Britten-Jones and A/Prof Ayton, a national survey led by the Centre for Eye Research and the University of Melbourne will investigate the knowledge and perspectives of optometrists on emerging treatments and management for inherited retinal disease.

  “The hope is we’ll be able to identify gaps in knowledge, and then develop targeted education programs for Australian clinicians,” says A/Prof Ayton.

  “This will ensure primary eyecare providers are up to date with the latest information, so that they can appropriately refer people for these exciting new treatments.”

  Through clinical trials, patient information and research-based surveys, there are many opportunities for optometrists to engage in research, particularly in terms of community-led research such as this.

  “It’s a pretty exciting time for optometrists to be engaged in research,” says A/Prof Ayton.

  “They don’t necessarily have to complete a PhD and be full time researchers, they can still be involved in research within their own practices by referring patients and giving them opportunities that they wouldn’t normally have.”

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• Introducing our Senior Manager, Philanthropy, Ryan McCarthy

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  Introducing our Senior Manager, Philanthropy, Ryan McCarthy

  CERA’s new Senior Manager, Philanthropy, Ryan McCarthy is looking forward to getting to know our supporters and is excited by the transformational potential of eye research.

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  After starting off as a volunteer, you’ve now been a professional fundraiser for more than 15 years. What inspired you to take on a career in philanthropy?

  I’ve been incredibly fortunate to have been surrounded by brilliant and inspiring people throughout my career in philanthropy, both by colleagues working to create a better world, and by individuals whose passion and generosity makes this work a possibility. Above all I am inspired by the good in people and by our ability to make a very real and positive difference in the lives of others.

  What do you love most about your job?

  I love meeting new people and feel very privileged to have an opportunity to listen to their stories. I love being able to bring people together to help each other and see their ideas and dreams become new realities.

  What attracted you to take on your new role at CERA?

  I am attracted to the visionary thinking taking place at CERA, and by CERA’s commitment to creating a culture of philanthropy that can achieve transformational change. I am attracted to a role which allows me to play a part in accelerating eye research and facilitating scientific breakthroughs that will have a profound and positive impact on the lives of people all over the world, and generations to come.

  What are you most looking forward to in your new role?

  It’s a very exciting time to be working at CERA, and ground-breaking developments in the diagnosis, prevention, and treatment of eye disease and vision loss are on the horizon. It’s a new journey for me and I’m looking forward to sharing in my colleague’s discoveries and connecting CERA’s work to our growing community. I’m particularly excited about seeing the progress of research to develop gene therapies for eye diseases which until very recently have been considered untreatable. And looking forward to working with supporters to increase our capability to bring more of these cutting edge treatments from around the world to Australian patients.

  We couldn’t do our research without the generous support of our donors. What have been your early impressions of the CERA community so far?

  In the brief time I have worked at CERA I have been deeply impressed by the generosity of our donors and by their commitment to realising a world free from vision loss. It is heartening to see that the CERA community is in such a close and collaborative relationship with our researchers and our work on the ground – they make it all possible.

  What’s an interesting fact you’ve learned about eye research that you didn’t know before?

  I’m fascinated by the eye’s ability to reflect and communicate such deep and detailed information about the health of the body. The use of novel imaging techniques, such as hyperspectral imaging, and artificial intelligence are being used by CERA researchers to predict health outcomes and changes in the brain that indicate signs of disease before symptoms appear. Eye research is truly at the cutting edge.

  More information

  For a confidential discussion about opportunities to support CERA’s research, you can contact Ryan on +61 3 9929 8796 or via email at rmccarthy@cera.org.au.

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  By including a gift in your will, your support for new medical discoveries to treat and cure eye diseases can continue.

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• Accelerating glaucoma research

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  Accelerating glaucoma research

  A new project at CERA is aiming to grow the cells that are lost in glaucoma in the lab, potentially creating new ways to study the disease.

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  One of the major challenges associated with glaucoma research is studying the cells that are damaged by the disease. Because glaucoma kills cells that are located right at the back of the eye, examining exactly how damage occurs, as well as testing the effectiveness of potential treatments, is not a simple task.

  New research underway at CERA is working to grow the cells that are damaged in glaucoma in the lab where they can be more easily studied. If the work is successful it would open the door to many new ways to study the condition and potentially lead to a treatment that could restore a patient’s sight.

  

  Faster testing: Dr Sushma Anand is trying to grow retinal ganglion cells in the lab.

  Retinal ganglion cells

  “Retinal ganglion cells are the particular cells that are lost or damaged in glaucoma patients,” says Dr Sushma Anand, research fellow at CERA. These cells, located at the back of the eye, transmit electrical signals from the eye to the brain.

  The exact causes of glaucoma are not fully understood, but the condition is often associated with increased pressure within the eye. There are already several treatments for glaucoma that reduce pressure in the eye in order to slow vision loss, but none that revive retinal ganglion cells and restore sight that has already been lost.

  Studying retinal ganglion cells is crucial to improving our understanding of glaucoma and developing new treatments, but right now that is very difficult to do.

  “If you want to study how retinal ganglion cells become dysfunctional, or how glaucoma patients lose their retinal ganglion cells, you need a sample of them to study,” says Dr Anand.

  However, taking a sample of retinal ganglion cells from a patient would be a very invasive procedure, making the condition impossible to study in the lab.

  Direct reprogramming

  Dr Anand’s new project, which is funded by a grant from The CASS Foundation, is aiming to develop a way to grow retinal ganglion cells in the lab.

  She is using a technique called ‘direct reprogramming’ which uses the expression levels of specific genes to transform cells from one type into another.

  For this project Dr Anand is taking skin cells, an easily sampled type of cell most found as a connective tissue throughout the body, into retinal ganglion cells.

  “We will introduce various neuronal genes to educate human skin cells to transform into neurons,” says Anand.

  The process is similar to how stem cells can be used to grow into another type of cell, but is much faster.

  “Stem cells have to go through all the developmental stages when they grow, so it takes a long time for a stem cell to convert into another cell. One experiment can take more than two months,” says Dr Anand.

  “Direct reprogramming takes between 15 and 21 days, so the time it takes to see if your experiment has worked is significantly reduced.”

  The process also has far fewer ethical challenges to using stem cells.

  If the process of direct reprogramming of skin cells into retinal ganglion cells can be standardised, it would provide a ready supply of cells for testing. With a greater supply of retinal ganglion cells, more work can be done testing medications to see if any have the potential to restore sight.

  “The ultimate goal of our project is to restore vision to patients,” says Dr Anand. “This is the first step towards that goal in the long term.”

  Dr Anand has wide experience working across different fields of research. Her doctorate was in cancer research, and her first piece of post-doctorate research was in structural immunology.

  She says that this wide experience has informed how she undertakes research.

  “A variety of experiences gives new perspectives.”

  Visit our 2022 Glaucoma Appeal page to make a donation and share our vision to beat glaucoma.

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