Iridex Corporation has successfully enrolled the first patient in the landmark DAME trial, an independent investigator-led study that could transform treatment approaches for severe diabetic macular edema (DME). The trial will evaluate whether adding subthreshold MicroPulse laser treatments to anti-vascular endothelial growth factor (anti-VEGF) therapy can provide equivalent visual outcomes while reducing treatment burden for patients with severe DME.
Study Design and Objectives
The DAME trial is designed as a pragmatic randomized equivalence trial that will enroll 264 participants across more than 20 clinical sites throughout the United Kingdom. Led by Principal Investigator Professor Noemi Lois at Queen's University Belfast, the study targets patients with severe DME, defined as having central retinal subfield thickness (CRT) of ≥400 μm once CRT goes below 400 μm.
The trial's primary outcome is to demonstrate equivalence in best-corrected visual acuity outcomes between treatment arms over a 24-month period. Secondary outcomes include quality of life measures, cost-effectiveness analysis, treatment burden assessment, and patient-reported experience metrics.
Addressing Current Treatment Limitations
Professor Lois emphasized the significant limitations of current DME treatment approaches. "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," she stated.
The DAME trial investigates a potential paradigm shift in treatment strategy. If successful, the study could demonstrate that continuing with subthreshold MicroPulse laser treatment once DME has improved following anti-VEGF therapy is equivalent to ongoing anti-VEGF monotherapy in terms of visual outcomes. This approach may substantially reduce the number of anti-VEGF injections required, subsequently decreasing risks, inconvenience, and costs for both patients and healthcare services.
Technology Platform
The study exclusively utilizes Iridex's IQ 577 laser in its MicroPulse treatment mode, paired with the TxCell Scanning Delivery Device. This technology platform 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, expressed confidence in the technology selection: "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."
Building on Previous Success
The DAME trial builds upon the foundation established by the DIAMONDS study, another independent, investigator-led, multi-center UK trial. The DIAMONDS study demonstrated the safety and effectiveness of subthreshold MicroPulse laser using the Iridex IQ 577 and TxCell Scanning Delivery Device in patients presenting with DME of less than 400 μm in CRT.
Implementation Strategy
The DAME trial includes a comprehensive implementation work package designed to develop a strategy for translating trial results into clinical practice. This component aims to create a blueprint for implementing the new treatment pathway into routine clinical care if the combination approach proves beneficial for DME patients.
The study is funded by the Health Technology Assessment of the National Institute for Health Research (HTA-NIHR) in the UK, underscoring the significant potential impact of this research on healthcare policy and practice. Professor Lois acknowledged this support, stating, "We are indebted to the National Institute for Health Research (NIHR) in the UK for having funded this trial."
