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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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Ext f/u of the Argus II Feasibility Study


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General
Study Status Completed
Application Number H110002 / PAS001
Date Current Protocol Accepted 02/13/2013
Study Name Ext f/u of the Argus II Feasibility Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Extending the Single-armed feasibility study
Study Population Description Subjects who have completed participation in the Investigational Phase of this study and who have the Argus II device still implanted are eligible for enrollment in the Post-Approval Phase of this study.
Sample Size N = 29. Fourteen (14) subjects were enrolled in the Investigational Phase of the study. One of these 14 subjects was explanted, which leaves a maximum of 13 subjects in the U.S. eligible for the post-approval phase of this study. An additional 16 subjects were enrolled in a similar study in Europe. All 16 of these subjects are eligible for participation in the post-approval phase of the study.
Data Collection The primary endpoint of the post-approval phase is safety (i.e. the rates of adverse events). The secondary endpoint of the post-approval phase the long-term reliability of the Argus II implant.
Follow-up Visits and Length of Follow-up Extend the subjects overall participation in the study to 10 years post-implant.
During year 5 to 7, every six month; from year 8 to 10 annually. Note the examinations are not exactly the same prior to year 7 and thereafter, because the study undergoing was extended to year 7.
Interim or Final Data Summary
Interim Safety Information A total of 30 subjects have been enrolled with an implant average implant average of 10.39 +/- 2.84 years (range 1.2 – 12.6 years). Of these, twenty-four subjects have completed full study participation (10 years) and one subject withdrew prior to completing study participation. Four (4) subjects in the study had the Argus II device explanted. The average post-explant duration is 6.6 +/- 4.0 years (range 1.6 – 11.4 years). None unanticipated adverse device events reported.
Actual Number of Patients Enrolled 30 subjects
Actual Number of Sites Enrolled 10
Patient Follow-up Rate % at 10 Yr- % Follow-up completed (calculated as a percent of expected follow-up)
N=30 (enrolled);
1 subject explanted at 1.2 years post-implant
N=29 completed 3 years follow-up (100%);
1 subject explanted at 3.5 years, 1 subject explanted at 4.3 years post-implant, 1 subject missed the 4-year and subsequent follow-up visits
N=26 completed 5-year follow-up (96%);
1 subject passed away at 6 years post-implant
N = 25 completed 7-year follow-up (96%);
1 subject explanted a
Final Safety Findings The primary endpoint for this study was the rate of device-related adverse events in the post-approval phase. A total of 36 serious and 152 non-serious device- or procedure-related adverse events were observed in the study, starting from 2007 through December 31, 2019.
Serious Adverse Events:
Conjunctival dehiscence 13% (4/30)
Conjunctival erosion 30% (9/30)
Corneal Melt - infective 3% (1/30)
Corneal opacity 3% (1/30)
Endophthalmitis - infective 13% (4/30)
Epiretinal membrane 3% (1/30)
Hypotony 17% (5/30)
Iridis Rubeosis 3% (1/30)
Keratitis - infective 3% (1/30)
Migration (extra-ocular) of intraocular silicone oil 3% (1/30)
Re-tack 7% (2/30)
Retinal detachment- rhegmatogenous 10% (3/30)
Retinal detachment- tractional and serous 3% (1/30)
Retinal Tear 3% (1/30)
Uveitis 3% (1/30)

Non-serious Adverse Events
360 Circumferential Vitreous Band Traction 3% (1/30)
Choroidal detachment 20% (6/30)
Choroidal effusion 3% (1/30)
Conjunctival congestion 37% (11/30)
Conjunctival Cyst 7% (2/30)
Conjunctival dehiscence 7% (2/30)
Conjunctival erosion 7% (2/30)
Conjunctivitis - inflammatory 17% (5/30)
Corneal abrasion 3% (1/30)
Corneal dryness 3% (1/30)
Corneal epithelial defect 3% (1/30)
Corneal fold 3% (1/30)
Corneal opacity 3% (1/30)
Corneal Suture Broken 7% (2/30)
Corneal vascularization 7% (2/30)
Decrease in light perception 3% (1/30)
Elective Revision Surgery 23% (7/30)
Epiphora 10% (3/30)
Epiretinal membrane 37% (11/30)
Fibrosis around Retinal tack 3% (1/30)
Fibrosis around tack 3% (1/30)
Filamentary keratitis 3% (1/30)
Foreign Body Sensation 7% (2/30)
Headache 10% (3/30)
High IOP 7% (2/30)
Hyphema 10% (3/30)
Hypotony 27% (8/30)
Inflammation -ocular 17% (5/30)
Irregular pupil 3% (1/30)
Keratic Precipitates 10% (3/30)
Nausea 3% (1/30)
Nystagmus increase 3% (1/30)
Ocular fibrin 3% (1/30)
Pain - ocular 60% (18/30)
Pre-retinal hemorrhage 3% (1/30)
Proliferative Vitreoretinopathy 3% (1/30)
Ptosis 7% (2/30)
Retinal Break/Tear 3% (1/30)
Retinal detachment-tractional 3% (1/30)
Retinal Folds 3% (1/30)
Retinal Thickening-cystoid macular edema (CME) 13% (4/30)
Retinal Thickening-without cystic changes 13% (4/30)
Retinoschisis 7% (2/30)
Revision Surgery - tack replacement 3% (1/30)
Rubeosis 3% (1/30)
Scleral graft displacement or reabsorption 3% (1/30)
Scleral patch displacement 3% (1/30)
Scleritis 3% (1/30)
Suture irritation 23% (7/30)
Uveitis 20% (6/30)
Vertigo 3% (1/30)
Vitreous hemorrhage 10% (3/30)

No unanticipated adverse events have been reported for this study.
Final Effect Findings The secondary endpoint for this study was the assessment of the long-term reliability of the Argus 2 System. Out of 30 implanted subjects, two implants failed—each experienced a decline in ability to create and maintain radiofrequency link with the glasses, ultimately leading to total loss of link. One of these failures occurred at 3.9 years post-implant, the other at 4 years post-implant.
In addition, four subjects were explanted due to recurrent conjunctival erosion (3), hypotony/subject request (1).

Study Strengths & Weaknesses The primary strength of this study is the long-term follow up of 30 subjects implanted with the Argus 2 System. This provided almost 300 subject-years of safety and reliability data of a first-in-human device.

Study weaknesses include the single-arm design and small sample size of 30 subjects.

Recommendations for Labeling Changes In the approved Argus 2 Retinal Prosthesis System Product Insert (page 181/379, H110002), reported adverse events, probable benefit, and implant failures should be updated with the outcomes of the “Extended Follow-up of the Argus 2 Retinal Stimulation System Feasibility Protocol (CP-003-001).” Similarly, in the Argus 2 Retinal Prosthesis System Patient Manual (page 340/379, H110002), Clinical Studies should be updated with this information.



Ext f/u of the Argus II Feasibility Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/14/2013 08/14/2013 On Time
one year report 02/13/2014 02/11/2014 On Time
18 month report 08/14/2014 08/18/2014 Overdue/Received
two year report 02/13/2015 02/13/2015 On Time
three year report 02/13/2016 02/16/2016 Overdue/Received
four year report 02/12/2017 02/06/2017 On Time
five year report 02/12/2018 02/13/2018 Overdue/Received
six year report 02/12/2019 02/11/2019 On Time
seven year report 02/12/2020 02/14/2020 Overdue/Received
final report 10/16/2020 10/16/2020 On Time


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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