The Australian team behind the Laser Intervention in the Early Stages of AMD (LEAD) study is now recruiting patients with age-related macular degeneration (AMD) who have early signs of atrophy or nascent geographic atrophy (nGA) for the new LIANA (laser intermediate AMD with nGA) study.
Published in 2019, the 36-month, multicentre, randomised, sham-controlled LEAD trial was led by Professor Robyn Guymer, deputy director and head of macular research at the Centre for Eye Research Australia (CERA). Her team evaluated the AlphaRET (formerly Ellex) 2RT nano-pulse ophthalmic laser therapy in 292 participants with bilateral large drusen and without OCT signs of atrophy.
“2RT stimulates a natural immune response of the retina, which restores natural metabolite flow and rejuvenates the retinal pigment epithelium,” said a statement from Nova Eye, the US company behind AlphaRET at the time of the LEAD study. Among the study’s conclusions was that subthreshold nanosecond laser treatment may have a role in slowing progression for AMD patients without coexistent reticular pseudodrusen (RPD) and may even be inappropriate in those with RPD.
While LIANA will investigate 2RT’s potential therapeutic role in AMD patients with signs of atrophy, Nova Eye is trying to raise capital for a separate international validation study for LEAD patients without atrophy, said Prof Guymer. “The LEAD trial results, as well as preclinical data, gave us a lot of data on the possibilities of 2RT for slowing progression (in patients without atrophy), but we need to do a validation study before we can claim it slows progression of AMD. I am working to undertake such validation studies,” she said.