The Centre for Eye Research Australia (CERA) is calling on optometrists across the country to help identify potential participants for a new clinical trial investigating a novel treatment for intermediate age-related macular degeneration (AMD).
The LIANA study, led by Professor Robyn Guymer AM, aims to evaluate the safety and efficacy of subthreshold nanosecond laser (SNL) treatment in slowing disease progression in patients with intermediate AMD and nascent geographic atrophy.
This is the second SNL treatment study led by Prof Guymer to evaluate the safety and efficacy of AMD treatment with 2RT nanosecond ophthalmic laser, a product developed in Australia by AlphaRET Pty Ltd, a wholly owned subsidiary of Nova Eye Medical Limited.
Prof Guymer said referring potential candidates with large drusen or intermediate AMD for assessment can significantly aid the research effort
The first, the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study was a 36-month, multicentre, randomised, sham-controlled trial, the results of which suggested that SNL treatment may be beneficial for certain AMD patients, particularly those without reticular pseudodrusen.
At its conclusion, Prof Guymer and her team followed patients for a further two years and were surprised to find that progression to geographic atrophy, as a whole, had slowed.
Building on this finding, she said “the LIANA study is intervening slightly later than the LEAD trial, when there’s already the very beginning signs of atrophy” or nascent GA, which weren’t included in the original study.
This new study aims to show that 2RT is safe for high-risk patients with intermediate AMD who are showing early signs of geographic atrophy, and that “it’s not too late to intervene when they’ve got those first signs of cell death”.
“The idea is that when we do get to the definitive study, it will be a slightly different design and able to be shorter because we’ve got the people at higher risk, the ones with the very early signs of atrophy,” Prof Guymer said.
Chance in a Lifetime
Prof Guymer said the promise of treatment addressing an unmet need within her professional lifetime has maintained her motivation to lead this second study.
“While we have treatments at the end of the disease, if you want to intervene early, really there’s nothing.”
Reflecting on her initial involvement, she said the 2RT laser treatment “looked promising in terms of the clinical outcome, and it really does have a biological rationale – in animal models it does look like it should work. So, I was attracted by the fact that there’s some good basic science behind it. It’s safe and seemed to have an efficacy signal in the LEAD study. And really there’s nothing else that’s likely in my lifetime to make a difference.”
Optometrists Best Placed
Optometrists are uniquely positioned to assist with recruitment, as patients with intermediate AMD often do not present at tertiary referral hospitals, or ophthalmology clinics, and may be asymptomatic.
While optometrists are not expected to identify the exact “sweet spot” for study eligibility, Prof Guymer said referring potential candidates with large drusen or intermediate AMD for assessment can significantly aid the research effort. Furthermore, these candidates may also be eligible for other studies in the future.
Melbourne, Sydney, and Adelaide Sites
The LIANA study has expanded beyond its site at CERA, to operate at the original LEAD sites in Sydney (led by Dr Jennifer Arnold), Adelaide (led by Dr Shane Durkin) and Melbourne (led by Associate Professor Wilson Heriot). This expansion aims to make participation more convenient for patients across Australia.
Optometrists interested in referring patients can find more information on the CERA website’s ‘Refer a Patient’ section. The research team will assess eligibility and, if appropriate, direct patients to the nearest study site.
Prof Guymer emphasised the importance of this research in the broader landscape of AMD treatment. While new injectable treatments for geographic atrophy are emerging, the nanosecond laser approach offers the potential for earlier intervention with a potentially safer profile.
“That’s the nice thing about a laser or a tablet, it’s pretty safe. So, you can start (treatment) earlier,” she noted. “We would like to stop atrophy in the first place, so patients don’t need expensive and ongoing injection treatments in the end.”
As the LIANA study progresses, Prof Guymer hopes it will pave the way for a larger, definitive trial that could solidify the role of nanosecond laser treatment in AMD management. By assisting with recruitment, optometrists have the opportunity to contribute to this potentially groundbreaking research and help advance care for their patients with AMD.
