The Laser Intervention in Early Age-Related Macular Degeneration (LEAD) clinical trial investigated the safety and efficacy of the nanosecond laser treatment as a preventative intervention to slow progression to late AMD. While the 36-month trial didn’t meet primary endpoints, post hoc analyses found that the 76% of patients who didn’t have coexistent reticular pseudodrusen (RPD) recorded a 77% reduction in the rate of progression from intermediate AMD to late AMD.
According to the company, the data provided important new information on the ideal patient cohort for treatment with Ellex 2RT.
“The significant reduction in the risk of progression to late AMD in the large subset of patients without coexistent RPD confers a significant first-mover advantage for our proprietary Ellex 2RT technology in these patients,” Ellex CEO Mr Tom Spurling said.
“We estimate the number of iAMD patients without RPD to represent at least approximately 15 million patients annually in Ellex’s existing 2RT markets. With no currently approved treatment options available for AMD in its early stages in these markets, or indeed anywhere in the world, we believe the LEAD data will be of significant clinical interest to retinal specialists and ophthalmologists seeking an intervention for patients with the early stages of AMD.”
The Centre for Eye Research Australia (CERA)’s Professor Robyn Guymer was the trial’s principal investigator, and she said it had shown a promising trend towards reducing the overall rate of disease progression in the treated eye of participants with large drusen (lipid rich deposits). However, while patients with less severe signs of AMD responded well to the treatment, participants with more severe signs of disease at the beginning of the trial (24% of participants) had a doubling of their progression rate when compared to those who were not treated.
“While this new laser isn’t a cure, and it is not suitable for every patient with AMD in its early stages, the impressive outcomes in reducing progression to late AMD are important as this is the first time that a laser intervention has shown promise in addressing AMD disease progression in more than 20 years of AMD laser research,” Guymer said.
“Based on our findings from the LEAD trial, new multimodal imaging techniques offer the ability to better stratify and monitor the progression of AMD patients. This is an important consideration for earlier stage interventions such as Ellex RT, where patient vision is largely unaffected. To that end, traditional outcome measures, including best corrected visual acuity (BCVA), do not adequately capture AMD disease status.”
The LEAD trial was a double-masked, randomised, sham-controlled study conducted over six sites. It involved 292 patients 50 years or older with a diagnosis of AMD, who had at least one large drusen in both eyes and no evidence of atrophy. Guymer is hoping to conduct further studies to validate the initial results
Article courtesy of: https://www.insightnews.com.au/Article3/1842/Ellex-laser-treatment-significantly-reduces-AMD-progression
