Iridex announces first patient enrolled in investigator-led study of MicroPulse

Iridex (IRIX) Corporation announced that the first patient has been successfully enrolled in the independent, investigator-led DAME Trial to evaluate the clinical efficacy, safety, cost-effectiveness, and patient acceptability of adding subthreshold MicroPulse treatments to anti-vascular endothelial growth factor therapy in patients presenting with severe diabetic macular edema. Led by Principal Investigator Professor Noemi Lois at Queen’s University Belfast, the study is designed to include at least 20 clinical sites and enroll 264 participants across the United Kingdom with severe DME, defined as having central retinal subfield thickness or greater than or equal to400 mum once CRT goes below 400mum. The trial is intended to develop a blueprint for the implementation of the new treatment pathway into clinical practice, if this is shown to be beneficial to people with DME.