ViscoPass: Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CyPass CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye |
Device: CyPass 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.
Other Names:
|
| Experimental: CyPass30 CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic |
Device: CyPass 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.
Other Names:
Device: Viscoelastic
Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent
|
| Experimental: CyPass60 CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
Device: CyPass 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.
Other Names:
Device: Viscoelastic
Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Transcend Medical Investigative Site | Lubeck | Germany | ||
| 2 | Transcend Medical Investigative Site | Mainz | Germany | ||
| 3 | Transcend Medical Investigative Site | Neubrandenburg | Germany | ||
| 4 | Transcend Medical Investigative Site | Panama City | Panama | ||
| 5 | Transcend Medical Investigative Site | Warsaw | Poland | ||
| 6 | Transcend Medical Investigative Site | Madrid | Spain |
Sponsors and Collaborators
- Transcend Medical, Inc.
Investigators
- Study Director: Alcon Research, Alcon Research
Study Documents (Full-Text)
More Information
Publications
None provided.- TMI-13-01
- GLD122-P001
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 6 study centers located in Germany (3), Poland (1), Spain (1), and Panama (1). |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | CyPass | CyPass30 | CyPass60 |
|---|---|---|---|
| Arm/Group Description | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| Period Title: Overall Study | |||
| STARTED | 60 | 21 | 61 |
| Completed Dose Selection Phase | 20 | 21 | 20 |
| Full Analysis Set | 60 | 21 | 61 |
| Safety Analysis Set | 60 | 21 | 61 |
| COMPLETED | 53 | 20 | 60 |
| NOT COMPLETED | 7 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | CyPass | CyPass30 | CyPass60 | Total |
|---|---|---|---|---|
| Arm/Group Description | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic | Total of all reporting groups |
| Overall Participants | 60 | 21 | 61 | 142 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
65.4
(9.87)
|
68.7
(9.68)
|
65.4
(11.17)
|
65.9
(10.42)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
37
61.7%
|
11
52.4%
|
29
47.5%
|
77
54.2%
|
| Male |
23
38.3%
|
10
47.6%
|
32
52.5%
|
65
45.8%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
32
53.3%
|
5
23.8%
|
36
59%
|
73
51.4%
|
| Black or African American |
10
16.7%
|
5
23.8%
|
2
3.3%
|
17
12%
|
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Other |
18
30%
|
11
52.4%
|
23
37.7%
|
52
36.6%
|
Outcome Measures
| Title | Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set with data available |
| Arm/Group Title | CyPass | CyPass30 | CyPass60 |
|---|---|---|---|
| Arm/Group Description | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| Measure Participants | 46 | 12 | 49 |
| Number [percentage of subjects] |
63.0
|
83.3
|
73.5
|
| Title | Percentage of Subjects With Device-related Ocular Adverse Events |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | CyPass | CyPass30 | CyPass60 |
|---|---|---|---|
| Arm/Group Description | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| Measure Participants | 60 | 21 | 61 |
| Intraoperative |
1.7
|
4.8
|
4.9
|
| Postoperative |
58.3
|
71.4
|
63.9
|
| Title | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set with data available |
| Arm/Group Title | CyPass | CyPass30 | CyPass60 |
|---|---|---|---|
| Arm/Group Description | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| Measure Participants | 60 | 21 | 60 |
| Baseline |
21.08
(5.004)
|
22.17
(6.683)
|
21.71
(5.279)
|
| Change from Baseline @ Month 12 |
-4.29
(5.360)
|
-4.00
(6.736)
|
-4.81
(6.406)
|
| Title | Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set with data available |
| Arm/Group Title | CyPass | CyPass30 | CyPass60 |
|---|---|---|---|
| Arm/Group Description | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| Measure Participants | 56 | 21 | 61 |
| Measure Eyes | 56 | 21 | 61 |
| Number [percentage of eyes] |
37.5
|
42.9
|
36.1
|
| Title | Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set with data available |
| Arm/Group Title | CyPass | CyPass30 | CyPass60 |
|---|---|---|---|
| Arm/Group Description | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| Measure Participants | 56 | 21 | 61 |
| Mean (Standard Deviation) [IOP-lowering medications] |
-0.8
(1.38)
|
-0.3
(1.74)
|
-0.8
(1.47)
|
Adverse Events
| Time Frame | Surgery through study completion, an average of 12 months. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis. | |||||||||||
| Arm/Group Title | CyPass Ocular | CyPass Nonocular | CyPass30 Ocular | CyPass30 Nonocular | CyPass60 Ocular | CyPass60 Nonocular | ||||||
| Arm/Group Description | Subjects with CyPass Micro-Stent implantation | Subjects with CyPass Micro-Stent implantation | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic | ||||||
All Cause Mortality |
||||||||||||
| CyPass Ocular | CyPass Nonocular | CyPass30 Ocular | CyPass30 Nonocular | CyPass60 Ocular | CyPass60 Nonocular | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| CyPass Ocular | CyPass Nonocular | CyPass30 Ocular | CyPass30 Nonocular | CyPass60 Ocular | CyPass60 Nonocular | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/60 (10%) | 4/60 (6.7%) | 1/21 (4.8%) | 0/21 (0%) | 7/61 (11.5%) | 2/61 (3.3%) | ||||||
| Eye disorders | ||||||||||||
| Eye disorder | 1/60 (1.7%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Hypotony of eye | 1/60 (1.7%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Maculopathy | 1/60 (1.7%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 3/61 (4.9%) | 0/61 (0%) | ||||||
| Narrow anterior chamber angle | 0/60 (0%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 1/61 (1.6%) | 0/61 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Respiratory tract infection | 0/60 (0%) | 1/60 (1.7%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Hyphaema | 0/60 (0%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 1/61 (1.6%) | 0/61 (0%) | ||||||
| Lumbar vertebral fracture | 0/60 (0%) | 1/60 (1.7%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Patella fracture | 0/60 (0%) | 1/60 (1.7%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Road traffic accident | 0/60 (0%) | 0/60 (0%) | 1/21 (4.8%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Investigations | ||||||||||||
| Intraocular pressure fluctuation | 1/60 (1.7%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Intraocular pressure increased | 4/60 (6.7%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 1/61 (1.6%) | 0/61 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Intervertebral disc protrusion | 0/60 (0%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 1/61 (1.6%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Lung neoplasm malignant | 0/60 (0%) | 1/60 (1.7%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Product Issues | ||||||||||||
| Device occlusion | 1/60 (1.7%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Bronchospasm | 0/60 (0%) | 1/60 (1.7%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 0/61 (0%) | ||||||
| Surgical and medical procedures | ||||||||||||
| Cataract operation | 0/60 (0%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 1/61 (1.6%) | 0/61 (0%) | ||||||
| Hospitalisation | 0/60 (0%) | 0/60 (0%) | 0/21 (0%) | 0/21 (0%) | 0/61 (0%) | 1/61 (1.6%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| CyPass Ocular | CyPass Nonocular | CyPass30 Ocular | CyPass30 Nonocular | CyPass60 Ocular | CyPass60 Nonocular | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/60 (63.3%) | 0/60 (0%) | 13/21 (61.9%) | 0/21 (0%) | 37/61 (60.7%) | 0/61 (0%) | ||||||
| Eye disorders | ||||||||||||
| Cataract | 13/60 (21.7%) | 0/60 (0%) | 3/21 (14.3%) | 0/21 (0%) | 14/61 (23%) | 0/61 (0%) | ||||||
| Visual acuity reduced | 20/60 (33.3%) | 0/60 (0%) | 7/21 (33.3%) | 0/21 (0%) | 19/61 (31.1%) | 0/61 (0%) | ||||||
| Investigations | ||||||||||||
| Intraocular pressure increased | 11/60 (18.3%) | 0/60 (0%) | 3/21 (14.3%) | 0/21 (0%) | 9/61 (14.8%) | 0/61 (0%) | ||||||
| Product Issues | ||||||||||||
| Device occlusion | 12/60 (20%) | 0/60 (0%) | 8/21 (38.1%) | 0/21 (0%) | 18/61 (29.5%) | 0/61 (0%) | ||||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Senior Clinical Project Lead, CDMA Surgical |
|---|---|
| Organization | Alcon Research |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- TMI-13-01
- GLD122-P001