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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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COMPASS XXT Post-Approval Study


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General
Study Status Progress Adequate
Application Number P150037 / PAS003
Date Current Protocol Accepted  
Study Name COMPASS XXT Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up PAS (COMPASS XXT; protocol GLD122-P004) 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 (COMPASS trial; G080209; TMI-09-01).
Study Population Description Subjects who completed the COMPASS trial, are able to understand the study requirements and willing to follow study instructions and are willing to return for required study follow-up visits.
Sample Size 374 eyes of 374 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.
Data Collection Safety outcome:
Rate of occurrence of sight-threatening adverse events (AEs)
Rate of occurrence of ocular AEs
Central and peripheral (nasal) endothelial cell density (ECD) measurements
Analyses of rate of loss and rate of low ECD (i.e., less than or equal to 1000 cells/mm2)
Assessment of stabilization of endothelial cell loss (ECL)
Corneal sequelae associated with ECL
Association between peripheral and central ECD count and number of observed rings
Secondary surgical interventions (SSIs) to modify the device position (e.g., repositioning, trimming, explanation)
Effects of SSIs on central and peripheral ECD
CyPass® Micro-Stent movement and/or malposition
Corneal AEs (e.g., corneal decompensation, tube corneal touch, corneal edema, etc.) caused by CyPass® Micro-Stent
Losses in Best Corrected Visual Acuity (BCVA) greater than or equal to 10 letters
Change in visual field mean deviation (MD)
Change in central corneal thickness
Effectiveness outcomes:
Mean intraocular pressure (IOP)
Proportion of subjects with a 20% or better reduction in IOP from COMPASS washed out baseline and on zero medication
Proportion of subjects with mean IOP less than or equal to 18 mmHg
Number of ocular hypotensive medications
Follow-up Visits and Length of Follow-up 10 years after CyPass stent implantation
Interim or Final Data Summary
Interim Safety Information 8 ongoing AEs in 6 subjects – 3 for CyPass obstruction, 3 for ECL, 1 BCDVA loss of 2 lines or more compared to best BCDVA from prior study, and 1 worsening of visual field mean deviation (MD) greater than or equal to 2.5 dB since exit of prior study.
There are 18 subjects with central ECD loss >30% (18/47, 38%) and 12 eyes (12/47, 26%) were observed with central ECD <1000 cells/mm2. Of these 19 eyes with either of the above ECD loss, 7 were reported with 2 rings visible and 3 are reported with 1 ring visible.
Gonioscopy
One eye had an increase in the number of rings visible since the 60-month visit in the COMPASS XT study from 1 to 2.
CyPass lumen occlusion was reported for 9 eyes, 3 of which were reported as AEs due to complete or partial CyPass obstruction.
Ten eyes reported with CyPass not visible, 7 of which are also reported with lumen occlusion.
Eleven eyes are reported with non-optimal CyPass position. Nine of these eyes were noted with either adequate or optimal position in the COMPASS or COMPASS XT trials.
Actual Number of Patients Enrolled 47
Actual Number of Sites Enrolled 14
Patient Follow-up Rate 9 out of 47 enrolled subjects (9/47, 19%) have completed follow-up
Follow-up is ongoing for remaining enrolled subjects
Subject contact is in progress for 71 of 204 (71/204, 34.8%) potential subjects (IDE cohort from enrolled sites)

Study Strengths & Weaknesses The data provided demonstrate continued loss of endothelial cells in these subjects. The rate of subjects with <1000 cells/mm2 is 26% in the enrolled subjects (12/47). The rate of enrolled subjects with >30% loss is 38% (18/47). The average change in ECD from Baseline for the 7 subjects that have completed follow-up to 10 years is -20.7%. Complete central ECD data has been analyzed for a consistent cohort from 3 months through 9 years to assess the yearly rate of ECL. The average ECL per year for up to 5 years for the consistent cohort was calculated to be 56.04 cells/mm2. The average rate up to 9 years (from 3 months) for this same cohort was calculated to be 59.79 cells/mm2. The average ECL per year from 5 through 9 years for this same cohort was calculated to be 64.24 cells/mm2. These data suggest that there is continued long-term ECL related to the CyPass device.


COMPASS XXT Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/09/2020 10/09/2020 On Time
1 year report 04/09/2021 04/08/2021 On Time
18 month report 11/09/2021 11/09/2021 On Time
2 year report 04/09/2022 04/08/2022 On Time
3 year report 04/09/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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