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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150037 / PAS001 |
| Date Original Protocol Accepted |
11/03/2016
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| Date Current Protocol Accepted |
11/03/2016
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| Study Name |
COMPASS Extension Study
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| Device Name |
CyPass Micro-Stent
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| Clinical Trial Number(s) |
NCT01085357
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| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up PAS (COMPASS trial; protocol TMI-09-01-E) is a long-term safety, multicenter, observational study with no planned interventions. The aim of the study is to evaluate the long-term safety of CyPass® Micro-Stent glaucoma implant in subjects who have completed participation of the IDE clinical trial (TMI-09-01).
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| Study Population |
Subjects who completed the protocol TMI-09-01, are able to understand the study requirements and willing to follow study instructions and are willing to return for required study follow-up visits.
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| Sample Size |
480 eyes of 480 subjects. This is based on the number of subjects implanted with the CyPass Micro-Stent, completed 24 month follow-up in study Protocol TMI-09-01 and will meet the study eligibility criteria
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| Key Study Endpoints |
• Primary safety outcome:
o Rate of occurrence of sight-threatening adverse events (AEs)
• Secondary outcomes- Safety:
o Best Corrected Visual Acuity (BCVA)
o Rate of occurrence of ocular AEs
o Slit lamp, goniscopy and fundus findings
o Visual field mean deviation (MD)
o Central corneal thickness
o Central corneal endothelial cell density (ECD)
o Rate of occurrence of CyPass movement, defined as a change by at least 1 in the number of CyPass rings visible (e.g., from 0 rings to 1 rings or from 3 rings to 2 rings) that does not result in clinical sequelae (e.g., secondary surgical intervention to modify device position, corneal endothelial touch by device, corneal edema leading to loss of BCVA > 2 lines at the last postoperative visit in comparison with preoperative BCVA, progressive endothelial cell loss (ECL), erosion of device through sclera, or device obstruction requiring secondary surgical intervention), and that is not attributable to:
- variations in gonioscopic viewing angle or illumination,
- changes in angle anatomy due to concomitant findings such as resolution of hyphema,
- changes in anterior chamber depth, or
- development of focal peripheral anterior synechiae
• Secondary outcomes- Effectiveness:
o Mean change in intraocular pressure (IOP)
o Proportion of subjects who are not using ocular hypotensive medication with = 20% reduction in IOP from baseline in the COMPASS Trial
o Proportion of subjects who are not using ocular hypotensive medication with IOP = 6 mmHg and = 18 mmHg
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| Follow-up Visits and Length of Follow-up |
5 years after the post-randomization from the COMPASS trial.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
282 US subjects
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| Actual Number of Sites Enrolled |
23 US sites
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| Patient Follow-up Rate |
Only 58.75% (282/480) of the eligible subjects were enrolled in the COMPASS-XT study. Of the 282 subjects enrolled, 253 completed the study.
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| Final Safety Findings |
The key finding from the COMPASS-XT study were the differences in mean endothelial cell density (ECD) and the percent change in ECD from baseline between the CyPass and Control groups after Month 24. Mean central ECD showed a greater loss in the CyPass group compared
to Control. The proportion of eyes with >30% loss in ECL between baseline and 60 months was greater in the CyPass group compared to the Control group.
Sight-threatening adverse events (AEs) were reported including incidence of Best Corrected Visual Acuity (BCVA) loss (2/213; 0.96%) in the CyPass group and retinal detachment (1/67; 0.30%) in the Control group. The total number of ocular AEs was 88 in the CyPass group and 16 in the Control group and included:
BCVA loss of 2 lines (10 letters) of more compared to BCVA reported in COMPASS study (24/215 (11.2%) in CyPass group and 4/67 (6.0%) in the Control group),
Confirmed worsening of visual field MD of greater than or equal to 2.5dB compared to COMPASS 24 Month visual field (22/215 (10.25%) in the CyPass group and 6/67 (9.0%) in the Control group),
Treatment of elevated IOP that is not satisfactorily managed using ocular hypotensive medication (10/215 (4.7%) in the CyPass group and 2/67 (3.0%) in the Control group),
CyPass device obstruction by iris, vitreous, lens, fibrous overgrowth, fibrin or blood (10/215 (4.7%)),
CyPass device malposition, dislodgement or movement (6/215 (2.8%)),
CyPass trimming (4/215 (1.9%),
Macular edema (3/215 (1.4%) in the CyPass group and 1.67 (1.5%) in the Control group),
Other maculopathy (3/215 (1.4%) in the CyPass group and 1.67 (1.5%) in the Control group),
Corneal edema (3/215 (1.4%) in the CyPass group and 1.67 (1.5%) in the Control group).
Other AEs reported in the COMPASS-XT are not listed here and were reported under 1% rate in the CyPass group.
Mean change in central corneal thickness from Month 24 were similar between the CyPass and Control groups.
Mean changes in VFMD from Month 24 were similar between the 2 groups.
Although no investigators reported device movement in the COMPASS-XT trial, changes in ring visibility not attributable to device trim were noted in 30 subjects.
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| Final Effect Findings |
46% of the subjects in the CyPass group had a 20% or greater reduction from baseline IOP without ocular hypotensive medications compared to 32% for the Control group.
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| Study Strengths & Weaknesses |
Strength:
¿ The continued IDE study identified long-term safety concerns that were not identified at 24 months.
Weaknesses:
¿ Only 58.75% (282/480) of the eligible subjects were enrolled in the COMPASS-XT study.
¿ Goniscopy data was not consistently collected in the study.
¿ Due to the small sample size at Month 60, it is difficult to draw a conclusion regarding the ECL.
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| Recommendations for Labeling Changes |
Labeling change is recommended to include the long-term safety information.
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