Reducing glaucoma blindness requires a fight on numerous fronts, so what efforts are currently being undertaken in Australia to curb the disease’s impact?
The clinical care model, treatments, patient support and advocacy have all been identified as important strands that need to be pulled together in order to reach the elusive 50% of Australians with glaucoma who are not aware they have the disease.
To coincide with World Glaucoma Week from 8-14 March, Insight has released a three-part feature, inviting Melbourne-based glaucoma expert Professor Keith Martin to speak about his promising gene therapy and how it may help those with severe glaucoma.
Dr Jack Phu, from the Centre for Eye Health, also discusses the impact of a new glaucoma care model that brings together ophthalmologists and highly trained optometrists, potentially easing the burden that is currently placed on the public health system.
And finally, Glaucoma Australia CEO Ms Annie Gibbins explains how the organisation has gone from supporting 200-300 patients annually to 5,500 within only two short years.
These three luminaries share with Insight their aspirations for the future of glaucoma care.
Glaucoma gene therapy: From pipedream to reality
The majority of glaucoma cases can be effectively managed, but what about those who don’t respond to treatment and are left facing the prospect of blindness? Gene therapy may be their best hope – and it might not be far away.
Despite its incurable status, glaucoma is no longer a disease that necessarily resigns patients to a lifetime of blindness or severe vision loss.
In fact, advances in glaucoma care, such as new classes of eyedrop, surgical techniques and laser approaches are helping to ensure a large majority of glaucoma patients avoid sight loss and maintain their quality of life.
While efforts continue to evolve and fine tune these management options, poor adherence, particularly with eye drops, often stands in the way of meaningful results. Today’s surgical options and implants can overcome this issue, but they may prove to be only a stepping-stone towards a truly revolutionary solution.
Centre for Eye Research Australia (CERA) managing director Professor Keith Martin is a researcher at the forefront of a movement focussing on how to stop glaucoma permanently – and even restore lost vision – through gene therapy.
At present, he believes there is no silver bullet that will solve all of glaucoma. Instead he says there are a range of strategies that are effective at different stages of the disease.
“There has been a lot of work developing technologies to lower the pressure inside the eye, but most of these technologies are not particularly revolutionary, they are more evolutionary,” Martin, who is also past president of the World Glaucoma Association, says. “Most of them are probably no more effective than the drugs and operations we already have but are potentially quicker or easier or with fewer side effects.
“I think there is still the need for these options, but most are aimed at people with relatively early glaucoma. At the other end of the spectrum, for people with very severe glaucoma, there is still a need for treatments that work over and above the effect on pressure and, ideally, restore vision once it’s been lost, rather than just slowing the decline.”
Part of the solution could be a gene therapy Martin is helping develop using a recombinant adeno-associated viral vector system. The virus works by introducing therapeutic genes to make retinal ganglion cells more resistant to damage. Initially, it is hoped the therapy would target the 10% to 15% of patients who don’t respond to regular treatment and are advancing towards blindness.
Martin began developing the therapy while at the University of Cambridge before co-founding Quethera in 2016, a Cambridge-based gene therapy company working to bring gene therapy to common eye diseases. That company is now a wholly-owned subsidiary of Japanese firm Astellas Pharma, which acquired the business for £85 million (AU$156 m). The therapy is making good progress towards investigational new drug status, a necessary step before human clinical trials. Martin is still involved in the program and will be continuing related work at CERA and the University of Melbourne.
“We hope to begin clinical trials in the next year or so and it will probably take two or three years for results to come through. We are also thinking hard about who are the most suitable patients,” he says.
“At the start it will be those with more severe and advanced disease where other treatments have failed, but it’s always difficult to give an absolute timescale because breakthroughs and progress don’t occur in a straight line in science.”
Due to the multiple gene defects affecting glaucoma, Martin’s work differs from gene editing techniques being trialled in inherited retinal diseases. However, he is buoyed by an appetite within ophthalmology to progress such therapies into real world care.
An example of this is Spark Therapeutics/Novartis’ Luxturna, which was the first gene therapy approved for an inherited retinal disease (Leber’s congenital amaurosis) by US regulators in 2017 and later in Europe in 2018.
Martin doesn’t need to look far to witness other important work occurring to tackle glaucoma at the genetic level. CERA is working with partners locally and nationally to establish Melbourne as Australia’s leading centre for ocular gene and cell therapy.
Australia, according to Martin, is also well placed to contribute towards personalised treatments that could one day consider the genetic make-up of any given patient. Underpinning this is the fact individual genomes can now be sequenced for a few hundred dollars.
“The likes of ophthalmologists Professor Jamie Craig in Adelaide, Professor David Mackey in Perth and Professor Alex Hewitt from CERA and the University of Tasmania have really made fundamental contributions to the world literature on the genetics of eye disease, including glaucoma,” he says.
“I think the next stage in that will be factoring genetic risk profiling into the way we manage glaucoma patients using the information of these studies to modify how we treat people and targeting more aggressive treatment to those of the highest genetic risk, and less to those that won’t.”
Martin says from a single cheek swab, health professionals can already determine the likelihood of someone getting glaucoma with 75% certainty.
“We are already starting to do that in the research setting, but what we don’t know is how to use that information in clinical practice. We are not at the stage where we recommend everyone does this, but we are starting to envisage this will be something that will be an important part of management – and not just for glaucoma.”
In the absence of a one-off treatment for glaucoma, ongoing treatment and management will continue to place a heavy burden on the health system.
Martin believes the problem could become more pronounced unless more thought is given to the current care model.
“As populations age, the number of people with glaucoma is increasing every year and yet the amount of resource that we have to treat all of these patients is not increasing at the same rate,” he says.
“So the question we are all asking is how do we shift resources away from people who don’t need them to those at the highest risk of life time blindness, and I think that’s a big question going forward.”
Carving an alternative pathway for glaucoma care
An overburdened public health system has left many glaucoma patients with little choice but to sit and wait for treatment. However, a unique collaborative care model could hold the key to overcoming this hurdle and many more.
Private care is out of the question for thousands of glaucoma patients across the country, but waiting times for treatment in the public system also poses a real problem.
In Australia, the current unmet demand for public hospital ophthalmology appointments has seen waiting periods for routine, non‐urgent referrals, including glaucoma, often exceed 12 months.
In response to this growing concern, in 2015 a novel hybrid model of collaborative care was established in New South Wales called the Glaucoma Management Clinic (GMC), an initiative of the Prince of Wales Hospital Ophthalmology Department and Centre for Eye Health (CFEH).
Funded by Guide Dogs NSW/ACT, the GMC at CFEH is a shared care service staffed by four to five highly trained optometrists on any given clinic day, technicians and a consultant ophthalmologist. They aim to reduce demands on ophthalmologists in the public system, providing an alternative pathway for patients with early or stable glaucoma.
“The GMC was activated after much planning from all parties concerned in response to the growing need for long-term glaucoma care,” CFEH lead clinician for glaucoma Dr Jack Phu says.
“Many of these patients are financially disadvantaged with over half (58%) reporting cost of attending private ophthalmology as being a factor for seeking a transfer of care to the GMC.
“The majority of our patients have difficulty accessing care through private channels and, as a result, wait long periods of time for outpatient care in a public hospital. The GMC is designed to reduce the burden to the public hospital outpatient clinic and reduce wait times for patients suitable for this model of care.”
Today the clinic runs once a fortnight and has grown from eight to 12 patients per clinic in 2015 to an average of 30 patients for the past six months. However, this number could rise in the future with plans to establish satellite clinics or, indeed, if it proves a more cost-effective alternative to the current models across both public and private glaucoma care.
To appreciate the potential benefits of the GMC model, Phu says it is important to understand its inner workings.
Patients seen within the clinic undergo a comprehensive glaucoma-specific clinical examination performed by an optometrist. The optometrist discusses the management plan with the consultant ophthalmologist before they both work together to formulate a plan.
The ophthalmologist provides oversight and manages complications as they arise, as per the current RANZCO and Optometry Board of Australia guidelines.
In between annual visits with the ophthalmologist, patients are evaluated in CFEH’s General Clinic and the optometrist makes decisions regarding the effectiveness of treatment and follow up periods, alongside virtual consultation with the ophthalmologist if required.
As per the guidelines, patients with advanced glaucoma and unsuitable for collaborative care are discharged from the service to the local hospital eye clinic for ongoing ophthalmological care.
Because CFEH is able to bill Medicare for the optometric services, there is an estimated clinician cost-neutrality for its service.
“While having the appropriate equipment is critical, the key features of the clinic are the expertise of the clinical team, the working relationships with the ophthalmologist, and patient review and critical review amongst the team,” Phu explains.
“There is mutual trust between optometrists and ophthalmologists that was built not overnight, but over four years of working side-by-side within the GMC and with more than 10 years of experience in tele-ophthalmology arrangements, providing clinical care but also collaborating in clinical research.”
Phu says the GMC is still young so CFEH is yet to analyse specific changes it has made on public ophthalmology demand.
However, two papers published to date, in which the CFEH’s senior staff optometrist and PhD candidate Ms Jessie Huang was the lead author, have investigated the implementation of the clinic and the impact of a referral refinement process for patients entering the GMC pathway.
In this work, the GMC has shown the vast majority of patients were appropriately managed, and the referral refinement process could effectively triage more than 95% of patients into the clinic that actually required ophthalmological evaluation and management. In combination, the clinic has shown the pathway is effective in identifying and managing patients who are appropriate for the GMC pathway and who may benefit from this option in lieu of others.
The clinic also provided timely patient management with a median wait time of 43 days. Phu anticipates the CFEH experience with the GMC – along with the research and publications associated with running the clinic – could help assess the role of a ‘no or minimal out-of-pocket’ care model that compliments private or traditional public sector eyecare.
“A cost and cost effectiveness study needs to address the condition-based approach of a GMC as an alternative to the current models of funding in either public hospital-based or private sector-based care. We are presently continuing our work with the Prince of Wales Hospital Ophthalmology Department in these areas.”
From the clinic, CFEH also produces clinical research that seeks to understand examination techniques (such as visual fields, imaging and intraocular pressure measurements) and pathways in order to refine them for more efficient and effective care.
Looking ahead, Phu says total cost recovery for the GMC remains a major goal. He believes this will require external funding outside of Guide Dogs NSW/ACT because Medicare rebates for optometric consultations are currently insufficient for full cost recovery.
As the GMC grows – and as CFEH develops satellite clinics elsewhere to reduce patient travel time – a key priority will be implementing and assessing a range of different models.
“Ultimately, half of all cases of glaucoma remain undiagnosed, and this is in part due to barriers to accessibility to services,” he says.
“There needs to be a collaborative attitude with all relevant stakeholders contributing to patient-centric pathways to minimise irreversible vision loss due to glaucoma. For these pathways to be sustainable, there needs to be an evolution of healthcare delivery at a high policy level, and optometrists need to prepare to change and also actively participate to meet these paradigm shifts.”
Energising the fight against glaucoma blindness
Glaucoma Australia CEO Annie Gibbins came to the role with an agenda to reform and modernise the organisation. Two years on, she reflects on the remarkable outcomes it has achieved and how this will shape the future.
To appreciate the transformation Glaucoma Australia (GA) has undertaken over the past two years, one only needs to look as far as the number of new glaucoma patients calling upon its services.
An organisation that historically fielded 200–300 glaucoma referrals annually, GA is now providing education and support to more than 5,500 people each year. From 2018 to 2019 that’s a 1730% increase and GA CEO Ms Annie Gibbins, who has been instrumental in this change, now has her sights set on 10,000 patients in 2020.
What makes this achievement all the more remarkable is that GA has managed this exponential growth while only increasing its staff by one fulltime equivalent (FTE) employee, taking its total number of employees to just six FTE.
“Enacting change requires clear strategy and laser focus. GA’s mission ‘to eliminate glaucoma blindness’ has always been bold and the board are 100% passionate about this intent,” Gibbins says.
As such, Gibbins has recognised there is no better time to strengthen GA’s status as the peak body and to use data to drive meaningful outcomes. It is this type of thinking that’s required if the sector is to reach the 50% of Australians who don’t know they have the disease.
Leading GA through a period of change is a task perfectly suited for Gibbins, who came to the organisation in February 2018 with a business transformation skillset forged across a career in health, education and change management CEO roles.
She has been influential in modernising and automating GA’s infrastructure, subsequently laying the groundwork for it to engage with more patients earlier in their glaucoma journey.
The first major project Gibbins oversaw was the design and implementation of a new four-stage referral pathway, which now forms the bedrock of every GA strategy:
Stage 1: Pre-Diagnosis / Suspected Glaucoma
Stage 2: Recently diagnosed and starting treatment
Stage 3: Six months post diagnosis
Stage 4: 12 months post diagnosis
“Previously, the main source of people accessing free support came by phoning the office, or filling out a brochure,” Gibbins explains.
“After listening in on those phone calls, we found many patients had had glaucoma for a very long time. While it is good for us to provide emotional and long-term support, our mission is to eliminate glaucoma blindness so we need to be educating and supporting patients at the earliest opportunity. We must be open to finding new ways to detect and defeat this disease.”
After securing buy-in from the ophthalmic sector, the referral pathway was implemented in May 2018.
With up to a third of glaucoma suspects (Stage 1) never attending their first ophthalmology appointment, GA needed to be more proactive to connect with this cohort.
That is why its integration with online referral platform Oculo has been a crucial component of its transformation. GA is now automatically notified when an eyecare professional suspects glaucoma, meaning the organisation no longer has to wait for patients to get in touch. This system is now responsible for approximately 65% of its total referrals.
“Once a referral has been made, the patient’s support journey is activated. As data is captured, GA are able to link the patient with their optometrist, ophthalmologist, and pharmacist which enables us to maximise the communication and support they receive,” Gibbins says.
With GA now dealing with 18x more patients than previously, a major challenge has been triaging the most important calls to the organisation’s single orthoptist educator.
As such, the organisation has designed an automated system that emails resources to patients depending on which of the four stages they fall into. The information helps patients maintain a clear focus on their immediate priorities to manage their disease.
If they require additional advice or don’t have access to computers, patients can then call GA to speak with the orthoptist.
Gibbins says Stage 2 and 3 patients require the most complex treatment advice and emotional support. For example, newly diagnosed patients (Stage 2) often need help processing information. Six months post-diagnosis patients (Stage 3) still have many questions and are usually coming to the end of their first prescription of eye drops, providing key information on adherence levels.
Due to these factors, these patients jump to the front of the queue to speak with the educator. However, that still leaves a backlog of calls from Stage 1 and 4 patients.
To cope with this, Gibbins initiated a new volunteer program mid-2019 comprised of 40 final year optometry and orthoptist students from several Australian universities. They are trained to give scripted advice to patients who have more general queries.
In turn, GA can sustain effective communication channels with patients while keeping its costs down, while the students gain valuable insight into the emotional concerns of glaucoma patients.
Between these initiatives, GA is now capable of expanding its service.
“Passion is great, but if you have a big vision you have got to have big capacity, so a great IT platform makes you scalable and more efficient in what you want to achieve,” Gibbins says.
“It also provides data which is critical to continual improvement. For example, we know the average age of patients being referred has dropped from 80-89 to 60-69, a trend GA hopes to continue.”
It is also hoped GA’s campaigns will have greater penetration in years to come, with Governor-General Mr David Hurley (patron) and INXS star Mr Kirk Pengilly (ambassador) coming on board for awareness projects.
This will all be important if GA is to meet its target of 10,000 referrals this year, with an eye on up to 30,000 in the distant future.
Gibbins’ short-term priority is to launch GA’s new website, making the patient experience easier to navigate. Looking ahead, she also wants to measure the impact of the new strategies using de-identified patient data.
“We will soon be starting annual surveys. We look forward to using evidence-based data to demonstrate GA patients have higher appointment and treatment adherence rates, plus broad ranging quality of life success measures.”
