Iridex Begins Patient Enrollment for Study on MicroPulse Technology as Complement to Anti-VEGF Therapy for DME

Key Takeaways

Iridex has begun its DAME trial, evaluating subthreshold MicroPulse treatments alongside anti-VEGF therapy for diabetic macular edema (DME).
The study will involve over 20 sites and aims to enroll 264 patients across the UK.
Principal investigator Professor Noemi Lois emphasizes the potential for this approach to reduce treatment burdens and costs for DME patients.

Trial Overview

Iridex has initiated the DAME trial, marking its first patient enrollment in an independent, investigator-led study. This trial aims to assess the clinical efficacy, safety, cost-effectiveness, and patient acceptability of integrating subthreshold MicroPulse treatments with anti-vascular endothelial growth factor (anti-VEGF) therapy in individuals with severe diabetic macular edema (DME).

Led by Professor Noemi Lois, MD, PhD, FRCS(Ed), FRCOphth, at Queen’s University Belfast, the study will involve over 20 clinical sites and strive to enroll 264 patients in the UK. Professor Lois noted that the current DME treatment heavily relies on frequent anti-VEGF injections, which can be costly and burdensome. These treatments often induce patient anxiety and have possible complications that could threaten vision. If successful, this trial could revolutionize the care for diabetic patients by potentially demonstrating that ongoing subthreshold MicroPulse laser treatments post anti-VEGF improvement are equally effective as continual anti-VEGF injections. This method may diminish the required number of injections, thus reducing complications, expenses, and overall inconveniences for patients.

Utilizing the Iridex IQ 577 laser’s MicroPulse treatment mode alongside the TxCell Scanning Delivery Device, clinicians can provide controlled treatments that prompt the retina’s natural healing without causing visible damage. Patrick Mercer, president and CEO of Iridex, expressed pride in the selection of their technologies for the DAME trial, underscoring their commitment to safe and effective DME patient treatments.

The DAME trial, independently led and pragmatically designed, is funded by the Health Technology Assessment of the National Institute for Health Research (HTA-NIHR) in the UK. The primary aim is to establish the equivalence in best-corrected visual acuity between treatment groups over a 24-month period. Secondary outcomes will evaluate quality of life, cost-effectiveness, treatment burden, and patient experiences, providing a comprehensive view of the implications of this potential new treatment protocol.

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