Iridex enrolls first patient in study evaluating MicroPulse technology as an adjunct to anti-VEGF therapy for DME

(Image Credit: AdobeStock/andrii)

Iridex has successfully enrolled the first patient in its independent, investigator-led DAME trial. The trial will evaluate the clinical efficacy, safety, cost-effectiveness, and patient acceptability of adding subthreshold MicroPulse treatments to anti-vascular endothelial growth factor (anti-VEGF) therapy in patients presenting with severe diabetic macular edema (DME).

The study will be led by principal investigator professor Noemi Lois, MD, PhD, FRCS(Ed), FRCOphth, at Queen’s University Belfast. The study itself will include over 20 clinical sites and plans to enroll 264 patients across the UK with severe DME.

Lois commented on the trial in a press release from Iridex, saying, “Current treatment for DME relies heavily on frequent anti-VEGF injections, which are not only expensive and burdensome to patients and healthcare systems but can also lead to patient anxiety along with having potential sight-threatening complications. DAME may transform the care of people living with diabetes and DME if the trial shows that continuing with subthreshold MicroPulse laser, once the DME has improved following anti-VEGFs, is equivalent in terms of visual outcomes to ongoing anti-VEGF therapy. This strategy may reduce the number of anti-VEGF injections required and, subsequently, risks, inconvenience, and costs to people and health care services.”

The Iridex IQ 577 laser in its MicroPulse treatment mode, paired with the TxCell Scanning Delivery Device, allows clinicians to deliver controlled, subthreshold treatment that activates the retina’s natural healing response without causing visible tissue damage.

Patrick Mercer, Iridex president & CEO, said, “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.”

The DAME trial is an independent, investigator-led, pragmatic, randomized equivalence trial funded by the Health Technology Assessment of the National Institute for Health Research (HTA-NIHR) in the UK. The primary outcome is equivalence in best-corrected visual acuity outcomes between treatment arms over a 24-month period, while secondary outcomes include quality of life, cost-effectiveness, treatment burden, and patient-reported experience.

References:

1. Iridex announces first patient enrolled in an independent landmark investigator-led UK study evaluating MicroPulse Technology as an adjunct to anti-VEGF therapy for diabetic macular edema. Published June 24, 2025. Accessed June 25, 2025. https://www.globenewswire.com/news-release/2025/06/24/3104105/0/en/iridex-announces-first-patient-enrolled-in-an-independent-landmark-investigator-led-uk-study-evaluating-micropulse-technology-as-an-adjunct-to-anti-vegf-therapy-for-diabetic-macula.html