|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
H110002 / PAS002 |
Date Original Protocol Accepted |
02/13/2013
|
Date Current Protocol Accepted |
05/13/2020
|
Study Name |
New Enrollment Argus II
|
Device Name |
ARGUS II RETINAL PROSTHESIS SYSTEM
|
Clinical Trial Number(s) |
NCT00407602
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Device Subjects Serve as Own Control
|
Analysis Type |
Analytical
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
New Enrollment Post-Approval Study: Multicenter prospective cohort study with Argus II System. Several controls are incorporated into the study. Data collected in the study will be compared with pre-implantation (Baseline) data. In addition, prospective comparisons will be made between the implant and fellow eyes, and by testing subjects visual performance with the Argus II System on and off.
|
Study Population |
Age 25 years or older; both males and females; with severe to profound retinitis pigmentosa; with bare or no light perception in both eyes or with retinal response to electrical stimulation; with previous history of useful form vision
|
Sample Size |
A total of 53 subjects will be enrolled in the study. It is anticipated that 85% of subjects will complete 5 years follow-up. This will provide a sample size of 45 subjects with complete 5 year follow-up. A minimum of 5 and a maximum of 40 centers in the US will participate in this study.
|
Key Study Endpoints |
Primary: Safety (i.e. adverse event rates), with the main safety analysis performed when all subjects have reached 2 years post-implant. Secondary: Visual function, functional vision, and device reliability
|
Follow-up Visits and Length of Follow-up |
5 years Baseline, implant, month 1, 3, 6, 12, 24, 36, 48, 60. Various follow-up assessments including medical and eye exam, functional evaluation will be tested at certain follow-up stages.
|
Interim or Final Data Summary |
Interim Results |
A total of 89 device or procedure-related adverse events have been reported to date. Of these, 15 were serious and 74 non-serious. None unanticipated adverse device events reported.
|
Actual Number of Patients Enrolled |
55 subjects
|
Actual Number of Sites Enrolled |
19
|
Patient Follow-up Rate |
77.4&
|
Study Strengths & Weaknesses |
This information will be included in the final report
|