iSTAR Medical initiates international STAR-VI trial for the use of MINIject in conjunction with cataract surgery
WAVRE, Belgium — 15 March 2022: iSTAR Medical, a medtech company delivering breakthrough eye care solutions to patients, today 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, multi-center, 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 two 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 intraocular pressure (IOP) from baseline to six-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.
Prof. Iqbal Ike K. Ahmed, 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 commented: “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.”
Mr Mahmoud Radwan, ConsultantOphthalmologist at The Colchester Eye Centre, Colchester (UK), an investigator in the STAR-VI trial commented: “It has been estimated1 that about one in five people undergoing cataract surgery also have glaucoma or ocular hypertension. The ability to treat patients for both cataracts and glaucoma at the same time benefits the patient, the surgeon, the health system as well as society through the efficiency of addressing two major causes of blindness concurrently, and by minimising patient recovery time and cost. I am pleased to be able to take part in the Company’s journey with MINIject to improve the lives of glaucoma patients undergoing cataract surgery.”
Michel Vanbrabant, CEO of iSTAR Medical, commented: “The initiation of our global STAR-VI trial is an important step to bring MINIject to more patients around the world, including to those with co-existing ocular conditions. We are committed to delivering our breakthrough eye care solutions to patients globally and look forward to reporting clinical data from this study in due course.”
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