Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma

Not Applicable

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Device: CyPass Micro-Stent; Device: Viscoelastic

• Registration Number: NCT02448875
• Lead Sponsor: Transcend Medical, Inc.

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).

Detailed Description

The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase.

Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye.

Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.

Study Timeline

• Study Start: 2013-06-21
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-20
• Primary Completion: 2017-06-22
• Study Completion: 2017-06-22
• Disposition First Submitted: 2018-06-05
• Disposition First Submitted QC: 2018-06-05
• Disposition First Posted: 2018-06-08
• Status Verified: 2019-05
• Results First Submitted: 2019-05-06
• Results First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-29
• Results First Posted: 2019-05-30
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Diagnosis of open angle glaucoma;
• Unmedicated IOP between 21 - 36 mmHg, inclusive;
• Normal angle anatomy at site of intended CyPass Micro-Stent implantation.

Exclusion Criteria

• Advanced glaucoma;
• Prior incisional glaucoma surgery;
• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
• Clinically significant ocular pathology other than glaucoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CyPass30	Viscoelastic	CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
CyPass60	Viscoelastic	CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
CyPass	CyPass Micro-Stent	CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye
CyPass30	CyPass Micro-Stent	CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic
CyPass60	CyPass Micro-Stent	CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication	Baseline (Day -1), Month 12 PostOperative	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months	Month 12 PostOperative	The use of ocular hypotensive medications was assessed in subjects with at least one IOP-lowering medication at 12 Months. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Mean Change From Baseline to 12 Months Postoperative in Medicated IOP	Baseline (Day -1), Month 12 PostOperative	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used	Screening (Day -2), Month 12 PostOperative	The number of IOP lowering medications in subjects at 12 months was compared to medicated baseline. A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Percentage of Subjects With Device-related Ocular Adverse Events	Up to Month 12 PostOperative	A device related adverse event (AE) was any AE that was considered to be possibly, probably, or definitely related to the device in the opinion of the investigator. Reported categorically as intraoperative (start date on the date of surgery) and postoperative (start date after surgery). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.

Trial Locations

Locations (1)

Transcend Medical Investigative Site; 🇪🇸 Madrid, Spain