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

Transcend Medical

Status: Completed

Conditions: Open Angle Glaucoma

Treatments: Device: CyPass Micro-Stent; Device: Viscoelastic

Study type: Interventional

Funder types: Industry

Identifiers

NCT02448875

TMI-13-01

GLD122-P001 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

CyPass

Active Comparator group

Description:

CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye

Treatment:

Device: CyPass Micro-Stent

CyPass30

Experimental group

Description:

CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic

Treatment:

Device: Viscoelastic

Device: CyPass Micro-Stent

CyPass60

Experimental group

Description:

CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic

Treatment:

Device: Viscoelastic

Device: CyPass Micro-Stent