iSTAR Medical initiates international STAR-VI trial for the use of its MIGS implant in conjunction with cataract surgery

According to a news release, 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. (Adobe Stock images)

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

According to a news release, 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.

“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,” said Iqbal Ike K. Ahmed, MD, Department of Ophthalmology and Visual Sciences, University of Utah, and chief innovation officer, Prism Eye Institute in Ontario, Canada, and an investigator in the STAR-VI trial, in the news release. “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.”

Moreover, Mahmoud Radwan, consulting ophthalmologist at The Colchester Eye Centre in Colchester, United Kingdom, and an investigator in the STAR-VI trial, said 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 minimizing patient recovery time and cost,” Radwan said. “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, in news release noted that the trial is a key step for the company.

“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,” Vanbrabant said. “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.”