Table 1 Complete and ongoing MicroShunt clinical studies
Study | Clinical study of the safety and performance of the Miami InnFocus Drainage Implant to relieve glaucoma symptoms [12] | Safety and performance of the Miami InnFocus Drainage Implant (MIDI Arrow) glaucoma drainage implant [11] | Postmarket study of the InnFocus MicroShunt [10] | InnFocus MicroShunt Versus Trabeculectomy Study (IMS) [13] |
|---|---|---|---|---|
NCT number (other study ID) | NCT00772330 (INN003) | NCT01563237 (INN004) | NCT02177123 (INN007) | NCT01881425 (INN005) |
Phase | 1 | 2 | Post market | 3 |
Control | Single arm | Single arm | Single arm | Randomized, parallel assignment, single masked |
Center(s) | 1 (Dominican Republic) | 1 (France) | 6 (France, the Netherlands, Spain, Switzerland) | 29 (France, Italy, the Netherlands, Spain, the UK, the USA) |
Follow up (years) | 5 | 2 | 2 | 2 |
Enrolled patients | 23 | 72 | 100 | 889 (estimated) |
Key inclusion criteria | Age: 18–85 years IOP: ≥ 18 and ≤ 40 mmHg inadequately controlled on tolerated medical therapy | Age: 18–85 years IOP: ≥ 18 and ≤ 35 mmHg on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery | Age: 40–85 years IOP: ≥ 15 and ≤ 40 mmHg on maximum tolerated medical therapy | |
Key exclusion criteria | Need for glaucoma surgery combined with other ocular procedures other than cataract surgery or anticipated need for additional ocular surgery during the study | Previous incisional ophthalmic surgery (excluding uncomplicated cataract surgery), or argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment | Previous conjunctival incisional ophthalmic surgery, anticipated need for additional ocular surgery during the study | |
Primary outcome | IOP reduction relative to baseline at 12 months | > 20% IOP reduction from baseline at 12 months without increasing the number of glaucoma medications | ||
Study start | October 2007 | June 2011 | April 2014 | August 2013 |
Primary completion | November 2016 | December 2016 | November 2017 | November 2018 |
Completion | January 2017 | January 2017 | November 2017 | November 2019 (estimated) |