Hydrus SUMMIT, CP 16-001, Rev 15Jun2017
Research type
Research Study
Full title
THE HYDRUS MICROSTENT FOR REFRACTORY OPEN-ANGLE GLAUCOMA: A PROSPECTIVE, MULTICENTER CLINICAL TRIAL
IRAS ID
230907
Contact name
Leon Au
Contact email
Sponsor organisation
Ivantis, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Research Summary
The objective of this study is to determine if the Hydrus Microstent can reduce intraocular pressure (IOP) in patients with refractory Open Angle Glaucoma (OAG). Study subjects will have documented elevated IOP of at least 20 mmHg in the study eye that has previously failed glaucoma surgery and with uncontrolled IOP on medical therapy or is on maximal tolerable medical therapy (MTMT). The study eye may be either phakic or pseudophakic. The addition of the Hydrus is expected to lower IOP, with the same or fewer glaucoma medications, with the potential to reduce the risk of progression. Subjects will attend a screening and baseline visit. Following surgery, they will return at 1 day, 1 week, 1, 2,3,6 and 12 months. A reduction of 20% or greater in IOP is considered to be clinically meaningful; thus the study will determine the percentage of subjects achieving this level of IOP reduction with the same or fewer medications as documented at the 12-month visit when compared to baseline.
Summary of Results
The objective of this study was to assess the effectiveness of the Hydrus Microstent for lowering of intraocular pressure (IOP) in patients with refractory open-angle glaucoma.
One hundred subjects underwent Hydrus Microstent implantation. At the completion of 12 months of follow up, the primary and secondary endpoints and safety outcomes were assessed. The safety population included all subjects for whom a Hydrus Microstent was implanted; no eyes had a failed attempt to implant. The effectiveness population consisted of all subjects undergoing the Hydrus implantation surgery; no subjects discontinued early from the study. The safety and effectiveness populations were the same in this study. For the primary effectiveness endpoint, a confidence level of 95% was calculated based on binomial distribution.
The primary effectiveness outcome for this study was defined as the proportion of subjects having a reduction of at least 20% (i.e., ≥20%) in mean diurnal IOP at 12 months while maintaining the same or fewer number of medications as at baseline. At 12 months, the primary effectiveness endpoint responder rate was 43.0% (95% CI: 33.1% to 53.3%). The secondary effectiveness endpoint, the mean diurnal change in IOP at 12 months compared to baseline, was -3.77 mmHg (SD ± 5.00, 95% CI: -4.76 to -2.77). About half of eyes (51.0%) benefitted from a decrease in the number of medications at 12 months compared to screening.
The safety outcomes included analysis of intraoperative and postoperative adverse events. Preoperatively, 74.0% of eyes had a previous glaucoma procedure with the most prevalent procedure being trabeculoplasty (57.0%), followed by trabeculectomy (19.0%).
Adverse events specifically related to the Hydrus were largely transient in nature and without clinical sequelae. There were no reports of endophthalmitis, choroidal detachment, or device corneal touch. Elevated mean IOP (≥10 mmHg over the qualifying baseline mean IOP) with onset after the first month postoperative was attributable to the discontinuation of hypotensive medications on the day of surgery. All events resolved within 1 month of onset with treatment with hypotensive medications and/or aqueous burp with the exception of 4 eyes where surgical re-intervention was eventually performed.
An adverse event for surgical re-intervention in the study eye was reported in 15 eyes (15.0%). All events were deemed not related to the device or procedure, and all events resolved without sequelae.REC name
North of Scotland Research Ethics Committee 1
REC reference
17/NS/0106
Date of REC Opinion
9 Nov 2017
REC opinion
Further Information Favourable Opinion