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Ellex’s 2RT therapy slows AMD progression in long term

09/07/2019By Myles Hume
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Ellex Medical Lasers’ 2RT Retinal Rejuvenation Therapy has been shown to have an enduring impact in slowing patients’ progression to late-stage age-related macular degeneration (AMD).

The Adelaide-based ophthalmic device manufacturer this week released the results of the four-year patient follow up of the landmark Laser Intervention in Early Age-Related Macular Degeneration (LEAD) clinical trial, which investigated the use of the nanosecond laser therapy in patients with intermediate AMD (iAMD)

“These data once again highlight the significant restorative effects of 2RT on retinal health in selected patients with intermediate AMD, resulting in a material delay in the time it takes for the disease to progress to late forms of the disease, where vision is impacted and patient quality of life declines markedly,” Ellex CEO Mr Ged Wallace said.

Ged Wallace, Ellex
Ged Wallace, Ellex
These data once again highlight the significant restorative effects of 2RT on retinal health in selected patients with intermediate AMD,”
Ged Wallace, Ellex

Published in September last year, the LEAD study was claimed to be the first time a laser intervention showed a promising clinical response among a large group of well-defined iAMD patients prior to progression to late AMD.

The study demonstrated that a subset of iAMD patients, without coexistent reticular pseudodrusen (RPD), who received 2RT therapy recorded a 77% reduction in the rate of progression from iAMD to late AMD when compared with patients receiving placebo treatment at three years.

Now, according to the latest data, Ellex reports that 183 of the original 292 participants attended a fourth-year post-LEAD follow up visit. The results confirmed the therapy was having a sustained rejuvenative effect on the retina.

Data from the observational study showed very little change in the clinical parameters study investigators reported at three years, despite no additional 2RT treatment for these patients beyond 30 months. At 48 months in patients without coexistent RPD at baseline, there was a 72% reduction in the rate of progression to late AMD versus sham, which is said to remain clinically significant.

Leading Italian retinal specialist Professor Andrea Cusumano, who has treated a number of patients with 2RT, said given its strong safety profile, it would be interesting to assess whether additional benefit could be conferred by treatment beyond 30 months.

“The durability of the 2RT treatment response well beyond the 30 months when selected iAMD patients last received this non-invasive therapy is compelling,” she said.

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“[This is] in light of current invasive treatment modalities, which are only approved for wet forms of late AMD and comprise ocular injections that need to be routinely performed every 8-10 weeks to limit further deterioration in visual acuity and help preserve retinal function.”

Participants in the post LEAD follow-up study will be followed for a further 12 months, at which time a scientific publication by the study investigators is expected to be submitted to a major medical journal.

 

More reading:

Ellex laser treatment significantly reduces AMD progression
Mapping Macula: The fight against blindness and vision loss
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