iSTAR Medical Initiates International STAR-VI Trial for the Use of MINIject in Conjunction with Cataract Surgery

iSTAR Medical announced that the first patients have been implanted in its STAR-VI international trial evaluating the safety and efficacy of MINIject` in conjunction with cataract surgery in patients with primary open-angle glaucoma.

iSTAR Medical’s STAR-VI trial is a prospective, interventional, multicenter, single-arm study which seeks to implant a total of 30 patients at up to seven sites in Europe and in Central America. Patients will be followed for 2 years after their cataract surgery and concurrent MINIject implantation. The primary endpoint of the trial is to measure the proportion of patients achieving a ≥20% reduction in diurnal IOP from baseline to 6-month follow-up, regardless of the use of IOP lowering medication.
 
MINIject is iSTAR Medical’s minimally-invasive glaucoma surgery (MIGS) device and is currently the only commercially available supraciliary MIGS implant.
 
“In the STAR series of trials, iSTAR Medical has established a consistent safety and efficacy profile for standalone use of MINIject in patients with open-angle glaucoma, harnessing the power of the supraciliary space. It is exciting to be involved with this new study, STAR-VI, to assess MINIject’s safety and efficacy also in combination with cataract surgery," Prof. Iqbal Ike K. Ahmed, MD, Department of Ophthalmology and Visual Sciences, University of Utah (USA), and Chief Innovation Officer, Prism Eye Institute, Ontario (Canada), an investigator in the STAR-VI trial, said in a company news release.