In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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 Description
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
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.
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
Followup Visits and Length of Followup
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.