Five-Year Safety And Efficacy Results Of A Supraciliary Drainage Device In Open Angle Glaucoma Patients (Star-Global)

The five-year safety and efficacy of a novel, minimally invasive glaucoma surgery (MIGS) device, MINIject® (iSTAR Medical, Wavre, Belgium), is described. The device was implanted ab interno into the supraciliary space in subjects with medically uncontrolled primary open-angle glaucoma.

The MINIject device was implanted in a standalone procedure in phakic and pseudophakic eyes in four prospective trials (STAR-I,II,III,IV). There was no medication washout. The trials were completed in 83 subjects in 11 sites in Europe, Asia and Central America with two-year follow-up.

Upon study completion, subjects from the STAR trials were invited to enrol into the STAR-GLOBAL study to continue follow-up annually from three until five years post implantation. Outcome measures were intraocular pressure (IOP), IOP-lowering medications, adverse events and measurement of corneal endothelial cell density (ECD). Fifty-six subjects from the STAR-I,II,III trials were enrolled in the STAR-GLOBAL trial, with 47 completing 5-year post-implantation follow-up (83.9%). These are preliminary, interim results of subjects only from the STAR-I,II,III trials who have now completed the STAR-GLOBAL trial at five years.

In this STAR-GLOBAL population, mean baseline diurnal IOP prior to implantation was 23.8±3.5 mmHg with a mean of 2.4±1.2 IOP-lowering medications (n=56). At 2-years post implantation, mean diurnal IOP was 14.3±4.2mmHg (-9.6mmHg, -39.5%; p<0.0001) on 1.4±1.4 medications in these subjects (n=55). At 5-year post-implantation follow-up (n=47), mean diurnal IOP was 14.8±5.6mmHg (-9.1mmHg, -38.4%; p<0.0001) on 1.5±1.4 medications (p<0.0001). Further, 83.0% of subjects achieved a >=20% IOP reduction, 78.7% of subjects achieved an IOP <=18 mmHg, and 31.9% of subjects were medication-free at 5 years. Since STAR-GLOBAL study enrolment, adverse events related to MINIject were two cases of ECD loss, one IOP increase and one iris rubeosis.

Standalone MINIject implantation resulted in a clinically significant reduction in IOP and hypotensivemedication use up to five years post-implantation in an ethnically diverse cohort of subjects. This supraciliary MIGS device offers an effective, bleb-free treatment option for patients with medically uncontrolled primary open angle glaucoma requiring low and sustained target IOPs.