WAVRE, Belgium, Dec. 19, 2018 /PRNewswire/ -- iSTAR Medical SA, a private medical device company developing novel ophthalmic implants for the treatment of glaucoma, today announced exceptional one-year results of the first-in-human, micro-invasive glaucoma surgery (MIGS) STAR-I trial, for the MINIject device in a standalone setting. Results demonstrate that MINIject is safe and highly effective in achieving significant intraocular pressure (IOP) reduction, as well as easing medication burden in glaucoma patients.
The trial demonstrated that the implantation of MINIject resulted in an average 32.6% IOP reduction to a mean of 15.6mmHg at one year. In addition, 75% of patients were able to discontinue topical medication usage and remained medication-free at one year. There were no serious ocular adverse events and no patient required subsequent glaucoma surgery.
The STAR-I trial is a prospective, open, international, multi-centre study in which MINIject was implanted in 25 patients with mild-to-moderate, primary open angle glaucoma uncontrolled by topical hypotensive medication. The aim is to assess the safety and performance of the MINIject device measured by IOP reduction under medication from baseline to six months, with follow-up to two years post-surgery.
Dr Ike Ahmed, University of Toronto, Ontario, Canada, performed some of the first MINIject procedures in the STAR-I trial. He commented: "The early performance of MINIject in providing significant pressure reduction in a standalone procedure, with 75% patients still medication-free and excellent safety at 1-year follow-up, has the potential to make a very real impact on improving quality-of-life for patients."
The MINIject supraciliary device is made of a soft and flexible, micro-porous material, and is implanted with a very small part of the device remaining in the anterior chamber. In the STAR-I study, endothelial cell density (ECD) results post-MINIject implantation showed minimal corneal cell loss compared with baseline at one-year follow-up (mean change -2%).
Dr Steven Vold, Ophthalmologist at Vold Vision, Arkansas, USA, has extensive experience implanting supraciliary MIGS devices. He said: "It is reassuring to see that after implantation with MINIject there was minimal change in mean ECD between baseline and one year. These efficacy and safety results are encouraging, and we look forward to having MINIject available for widespread use for our glaucoma patients."
Publication of results in a leading medical journal is expected in 2019.
ClinicalTrials.gov identifier: NCT03193736