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HomeminewsIntermediate AMD Patients Needed for New CERA Trial

Intermediate AMD Patients Needed for New CERA Trial

As shown via transmission electron microscopy, 2RT® triggers the monocyte function of the retina, signalling a change in immune modulation. Image courtesy of Erica Fletcher, Professor Anatomy and Physiology, The University of Melbourne.

The Centre for Eye Research Australia (CERA) is urgently seeking intermediate age-related macular degeneration (AMD) patients, to take part in a new pilot study, investigating the effect of the Australian designed and manufactured 2RT laser.

CERA’s Principal Investigator Professor Robyn Guymer AM is asking Australian eye care professionals to consider referring relevant patients to the LIANA study.1 This study follows the landmark LEAD study.

We are looking for people with large drusen (>125um) in both eyes… but at least one eye needs to be slightly more advanced, showing signs of the beginning of cell death, or atrophy

Candidates for the trial should be over 50 with large drusen in both eyes. People with late AMD in either eye are not able to be included.

“We are looking for people with large drusen (>125um) in both eyes (intermediate AMD or iAMD), but at least one eye needs to be slightly more advanced, showing signs of the beginning of cell death, or atrophy (nascent geographic atrophy). Drusen characterises the earlier stages of AMD, when people still have excellent vision but at risk of progressing to vision loss. This new study investigates the possibility of slowing intermediate AMD cases that have just started to show signs of progression to late-stage dry AMD.

“If patients with iAMD referred in do not have these early signs of atrophy, we can still register them for our larger multinational randomised clinical trial, planned to commence in 2023, which will recruit iAMD participants with and without these signs of atrophy,” Prof Guymer said.

Promising Trends

In the LEAD study, Prof Guymer reported that the 2RT nanosecond laser treatment showed a promising trend towards reducing the overall rate of disease progression in the treated eye of participants with large drusen, as long as the eye did not also have reticular pseudodrusen (RPD).2

Different clinical groups appeared to respond differently to the treatment during the LEAD trial. Patients with iAMD, but no RPD (representing 76% of the participants) showed nearly a four-fold decrease in progression rate of their disease.

“The LIANA study will also work on improving methods to show that there are beneficial functional benefits as well. We lead the world in this understanding of function in early stages of AMD, and the results obtained in this smaller LIANA trial, which is only being conducted at CERA in Melbourne, will help inform the functional testing and analysis to be undertaken in the larger validation studies planned to start next year,” Prof Guymer said.

LIANA Study

She said recruitment is underway for the LIANA study. Half the participants will get treatment with the 2RT, the other half will receive a sham treatment.

Participants need to be able to visit CERA in Melbourne approximately four times over a year – for screening, treatment, and review.

“The end goal is a treatment for intermediate AMD, for which there is currently none which are proven to so slowing down the progression of AMD. The LEAD study gave us a good indication that this approach might work when we conducted a post hoc analysis of the data. Thus, our aim is to validate these findings in a large definitive study. Before we embark on the large multinational study, the LIANA study at CERA will provide additional learnings to help design the best trial possible,” Prof Guymer said.

AMD is the leading cause of blindness and severe vision loss in Australia.

The 2RT nanosecond ophthalmic laser is a product of AlphaRET Pty Ltd, a wholly owned subsidiary of Nova Eye Medical Limited, a medical technology company committed to advanced ophthalmic treatment technologies.

Find out more about the LIANA trial on CERA’s website at: www.cera.org.au/trials/subthreshold-laser-treatment-in-intermediate-age-related-macular-degeneration-with-nascent-geographic-atrophy-study-liana/

CERA provides options for eye care professionals to refer a patient and for patient self -referral

You can also contact study investigators via email: [email protected].

References
1. LIANA stands for Laser for Intermediate AMD with Nascent geographic Atrophy.
2. See: https://www.cera.org.au/world-first-laser-treatment-shows-promise-in-slowing-ageing-eye-disease/