Ellex announces results of interim review of trial

Company News

Adelaide-based Ellex Medical Lasers (ASX:ELX) has announced the completion of an interim review of the initial participants in a clinical trial of its 2RT retinal rejuvenation laser as a treatment for intermediate stage age-related macular degeneration (AMD).

The company said the interim review was conducted without unmasking to maintain ongoing trial integrity. It confirmed that, as a result of the interim review, the trial will continue its full course through to at least April 2018.

“We are very pleased to report that the trial has passed this important milestone and will continue. This milestone was achieved based on the recommendation from the lead investigator on the trial. The analysis reported a meaningful difference in drusen progression and retinal sensitivity between the two groups, one of which received sham treatment and the other 2RT treatment. It also demonstrated a good safety profile,” said Ellex CEO Tom Spurling.

The Laser intervention in Early Age-related macular Degeneration (LEAD) trial is a double-masked, randomised, sham-controlled trial being conducted over six sites - five in Australia and one in Northern Ireland.

The lead investigator of the LEAD trial is Professor Robyn Guymer, MBBS, PhD, FRANZCO, a world-leading retinal professor based at the Centre for Eye Research Australia (CERA) in Melbourne.

There are 292 participants in the trial. The 292nd participant was recruited and randomised in April 2015. Participants have been randomly assigned to the 2RT laser or sham treatment groups (145 participants in 'Group 1' and 147 participants in 'Group 2').

According to the company, each participant is being comprehensively reviewed at six-monthly intervals over a total period of 36 months. The 36-month review period will be completed for the last randomised patient in April 2018.

Repeat treatment is being conducted at each 6 month review if the participant remains eligible for re-treatment.