Open Angle Glaucoma
Conditions
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.
Interventions
DEVICECyPass Micro-Stent
Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.
DEVICEViscoelastic
Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent
Sponsors
Transcend Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
Countries
Germany, Panama, Poland, Spain
Participant flow
Recruitment details
Subjects were recruited from 6 study centers located in Germany (3), Poland (1), Spain (1), and Panama (1).
Pre-assignment details
Of the 192 enrolled, 49 subjects were exited prior to randomization. In addition, one randomized subject discontinued prior to treatment. This reporting group includes all treated subjects, Dose Selection Phase and Expansion Phase (142 subjects).
Participants by arm
| Arm | Count |
|---|---|
| CyPass CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | 60 |
| CyPass30 CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | 21 |
| CyPass60 CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic | 61 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 |
| Overall Study | Investigator Decision | 3 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | CyPass | CyPass30 | CyPass60 | Total |
|---|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 9.87 | 68.7 years STANDARD_DEVIATION 9.68 | 65.4 years STANDARD_DEVIATION 11.17 | 65.9 years STANDARD_DEVIATION 10.42 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 5 Participants | 2 Participants | 17 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 18 Participants | 11 Participants | 23 Participants | 52 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 5 Participants | 36 Participants | 73 Participants |
| Sex: Female, Male Female | 37 Participants | 11 Participants | 29 Participants | 77 Participants |
| Sex: Female, Male Male | 23 Participants | 10 Participants | 32 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 21 | 0 / 21 | 0 / 61 | 0 / 61 |
| other Total, other adverse events | 38 / 60 | 0 / 60 | 13 / 21 | 0 / 21 | 37 / 61 | 0 / 61 |
| serious Total, serious adverse events | 6 / 60 | 4 / 60 | 1 / 21 | 0 / 21 | 7 / 61 | 2 / 61 |
Outcome results
Primary
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication
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.
Time frame: Baseline (Day -1), Month 12 PostOperative
Population: Full Analysis Set with data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass | Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication | 63.0 percentage of subjects |
| CyPass30 | Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication | 83.3 percentage of subjects |
| CyPass60 | Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication | 73.5 percentage of subjects |
Secondary
Mean Change From Baseline to 12 Months Postoperative in Medicated IOP
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.
Time frame: Baseline (Day -1), Month 12 PostOperative
Population: Full Analysis Set with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CyPass | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | Baseline | 21.08 millimeters of mercury (mmHg) | Standard Deviation 5.004 |
| CyPass | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | Change from Baseline @ Month 12 | -4.29 millimeters of mercury (mmHg) | Standard Deviation 5.36 |
| CyPass30 | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | Baseline | 22.17 millimeters of mercury (mmHg) | Standard Deviation 6.683 |
| CyPass30 | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | Change from Baseline @ Month 12 | -4.00 millimeters of mercury (mmHg) | Standard Deviation 6.736 |
| CyPass60 | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | Baseline | 21.71 millimeters of mercury (mmHg) | Standard Deviation 5.279 |
| CyPass60 | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | Change from Baseline @ Month 12 | -4.81 millimeters of mercury (mmHg) | Standard Deviation 6.406 |
Secondary
Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used
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.
Time frame: Screening (Day -2), Month 12 PostOperative
Population: Full Analysis Set with data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CyPass | Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used | -0.8 IOP-lowering medications | Standard Deviation 1.38 |
| CyPass30 | Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used | -0.3 IOP-lowering medications | Standard Deviation 1.74 |
| CyPass60 | Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used | -0.8 IOP-lowering medications | Standard Deviation 1.47 |
Secondary
Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months
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.
Time frame: Month 12 PostOperative
Population: Full Analysis Set with data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass | Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months | 37.5 percentage of eyes |
| CyPass30 | Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months | 42.9 percentage of eyes |
| CyPass60 | Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months | 36.1 percentage of eyes |
Secondary
Percentage of Subjects With Device-related Ocular Adverse Events
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.
Time frame: Up to Month 12 PostOperative
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CyPass | Percentage of Subjects With Device-related Ocular Adverse Events | Intraoperative | 1.7 percentage of subjects |
| CyPass | Percentage of Subjects With Device-related Ocular Adverse Events | Postoperative | 58.3 percentage of subjects |
| CyPass30 | Percentage of Subjects With Device-related Ocular Adverse Events | Intraoperative | 4.8 percentage of subjects |
| CyPass30 | Percentage of Subjects With Device-related Ocular Adverse Events | Postoperative | 71.4 percentage of subjects |
| CyPass60 | Percentage of Subjects With Device-related Ocular Adverse Events | Postoperative | 63.9 percentage of subjects |
| CyPass60 | Percentage of Subjects With Device-related Ocular Adverse Events | Intraoperative | 4.9 percentage of subjects |