Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial

Philippe Denis, Christoph Hirneiß, Georges M Durr, Kasu Prasad Reddy, Anita Kamarthy, Ernesto Calvo, Zubair Hussain, Iqbal K Ahmed, Philippe Denis, Christoph Hirneiß, Georges M Durr, Kasu Prasad Reddy, Anita Kamarthy, Ernesto Calvo, Zubair Hussain, Iqbal K Ahmed

Abstract

Background/aims: The current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma.

Methods: This prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication.

Results: Mean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (-40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm2 (n=26) to 2341 cells/mm2 (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD.

Conclusion: This first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events.

Trial registration number: NCT03193736.

Keywords: Anterior chamber; Aqueous humour; Glaucoma; Intraocular pressure; Treatment surgery.

Conflict of interest statement

Competing interests: PD: iSTAR Medical, Alcon, Allergan, Glaukos, Santen, Thea; CH: iSTAR Medical, Thea Pharma; GMD: Alcon, Allergan, Bausch & Lomb, Glaukos, Labtician, Novartis, MST, Santen, Sight Sciences; KPR, AK, EC: no financial interests; ZH: Vice President of Regulatory and Clinical at iSTAR Medical; IKA: Aequus, Aerie Pharmaceuticals, Alcon, Allergan, ArcScan, Bausch & Lomb, Beaver Visitec, Camras Vision, Carl Zeiss Meditec, CorNeat Vision, Ellex, ElutiMed, Equinox, Genentech, Glaukos, Gore, Iantech, InjectSense, Iridex, iSTAR Medical, Ivantis, Johnson & Johnson Vision, KeLoTec, LayerBio, Leica Microsystems, MicroOptx, New World Medical, Omega Ophthalmics, PolyActiva, Sanoculis, Santen, Science Based Health, Sight Sciences, Stroma, TrueVision, Vizzari.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
MINIject implant (iSTAR Medical, Wavre, Belgium) made of STAR material. Reprinted from Denis et al, copyright (2019), with permission from Elsevier and the American Academy of Ophthalmology.
Figure 2
Figure 2
Mean intraocular pressure (mmHg) with 95% CI error bars from baseline to 24-month follow-up in the intention-to-treat population.
Figure 3
Figure 3
Example ultrasound biomicroscopy images at week 1 (left) and 24-month (right) follow-up.

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