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Rheopheresis trial does not show statistical significance

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ST. LOUIS — Preliminary results from a pivotal trial on rheopheresis for the treatment of dry age-related macular degeneration found the treatment “did not demonstrate a statistically significant difference in the mean change of best corrected visual acuity,” according to a press release from TLC Vision.

The trial, dubbed MIRA-1, is a randomized, prospective, multicenter, double-masked pivotal phase 3 trial comparing rheopheresis treatment against placebo in 180 patients with late-stage, high-risk dry AMD who have demonstrated elevated plasma levels of select hemorrheologic macromolecules in their blood, according to OccuLogix, the company running the trial.

At 12 months after the initial treatment, there was not a statistically significant difference between the treated and placebo groups when applying the EDTRS scale, TLC said in the release.

“As expected, the treated group demonstrated a positive response,” the release said. “An anomalous response of the control group is the principal reason that the primary efficacy endpoint was not met.”

TLC Vision has a 51% interest in OccuLogix.