Iridex Enrolls First Patient in DAME Trial for MicroPulse in DME

Iridex has announced the enrollment of the first patient in the DAME trial, an independent, investigator-led study evaluating the addition of subthreshold MicroPulse laser therapy to anti-VEGF treatment in patients with severe diabetic macular edema (DME).

Study Design and Objectives

Led by Professor Noemi Lois, MD, PhD, FRCS(Ed), FRCOphth at Queen’s University Belfast, the DAME trial will be conducted across more than 20 clinical sites in the UK, enrolling a total of 264 patients with severe DME. The study is structured as a pragmatic, randomized equivalence trial, funded by the Health Technology Assessment of the National Institute for Health Research (HTA-NIHR).

The primary objective is to assess equivalence in best-corrected visual acuity outcomes between treatment arms over a 24-month period. Secondary endpoints include measures of quality of life, cost-effectiveness, treatment burden, and patient-reported experience.

Addressing the Burden of Current DME Treatments

Professor Lois highlighted the potential impact of the trial in a statement released by Iridex, noting that current management of DME depends heavily on frequent anti-VEGF injections. These treatments, while effective, are costly, can be burdensome to both patients and healthcare systems, and may induce patient anxiety or lead to sight-threatening complications. Lois emphasized that if the DAME trial demonstrates that continuing with subthreshold MicroPulse laser after initial anti-VEGF-induced improvement offers comparable visual outcomes to sustained anti-VEGF monotherapy, it could significantly reduce the number of injections required—lowering risks, inconvenience, and overall costs.

Role of Iridex MicroPulse Technology

The study will utilize the Iridex IQ 577 laser in its MicroPulse mode, coupled with the TxCell Scanning Delivery Device. This technology enables precise subthreshold laser applications that stimulate the retina’s natural healing processes without causing visible tissue damage.

Patrick Mercer, President & CEO of Iridex, commented, “We are honored that our IQ 577 laser, MicroPulse, and TxCell technologies are trusted as the exclusive platform for the DAME trial. Our technology enables consistent, safe, and effective treatments for DME patients, and we are excited to see its additional use investigated in this large-scale trial led by these respected clinicians.”