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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment Study

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Application Number P080030 / PAS002
Current Plan Approved 05/13/2016
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Initial Phase:

Prospective, randomized, concurrently controlled, parallel group, multicenter investigation

Surgery consisting of implantation of one (1) GTS100 stent in conjunction with cataract surgery, or cataract surgery only

1:1 randomization plan (treatment group to control group)

Washout of ocular hypotensive medications at Month 23 (if on medications)

Follow-up through 3 years postoperative

Revised Phase:

Prospective, controlled, multicenter investigation

Surgery consisting of implantation of one (1) GTS100 stent in conjunction with cataract surgery (treatment group)

Surgery consisting of cataract surgery only in subjects randomized to control group in the GC-007 and GC-008 trials and the initial phase of GTS100-PAS2 (control group)

Washout of ocular hypotensive medications at Month 23 (if on medications)

Follow-up through 3 years postoperative

Study Population Description Males or Females, 22 years of age or older

Sample Size 180 eyes of 180 subjects will comprise the treatment group. In addition, subjects randomized to cataract surgery only during the initial phase of this trial are included in the total study subject population. Subjects will be enrolled at a minimum of 20 sites and up to 45 sites; it is expected that about 400 subjects or more will undergo screening and baseline exams and operative procedures in order to obtain 180 eyes that received a GTS100 stent in conjunction with cataract surgery.

With estimated rates of 0.03 (3%) for PT and PC at 5 years, a Type I error rate of 5%, a Type II error rate of 20% (i.e., 80% power), a randomization ratio of 1:1, 1-sided testing, a two-group large-sample normal approximation test of proportions, and a ? of 0.05 (i.e., a non-inferiority margin of 0.05 or 5%), the required sample size is 288 subjects (or 144 per group). Due to the age of the study population, it is estimated that the study will have a drop-out rate of 20%.

Data Collection The primary endpoints will be the occurrence of STAEs. The STAEs include best corrected visual acuity (BCVA) loss ? 3 lines, endophthalmitis, corneal decompensation, retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection.

Other important ocular adverse events includes increase in intraocular pressure (IOP) of ? 10 mmHg at any time postoperative, and loss of best spectacle corrected visual acuity of ? 2 lines (? 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative.

Additional safety events of interest include findings from IOP, best spectacle corrected visual acuity (BSCVA), visual field, pachymetry, and specular microscopy measurements, stent dislocation, stent migration, stent obstruction, secondary procedures, such as additional surgical procedures to lower IOP, and findings from slit-lamp, fundus and gonioscopic examinations.

The effectiveness outcomes, although not the primary endpoint of this safety study, are the outcomes of mean diurnal IOP reduction ? 20% vs. baseline IOP without ocular hypotensive medication, and mean diurnal IOP ? 18 mmHg without ocular hypotensive medication, at 24 months. The rate of these effectiveness outcomes will be compared between the treatment and control groups.

Follow-up Visits and Length of Follow-up Three years

Visit 1 Screening (day -60 to day -5)

Visit 2 Baseline (after completion of appropriate medication washout period)

Visit 3 - Operative

Visit 4 6 Hours (+/- 4 hours)

Visit 5 Day 1 (+1 day)

Visit 6 Week 1 (7 +/- 2 days)

Visit 7 Month 1 (4 weeks +/- 7 days)

Visit 8 Month 3 (13 weeks +/- 14 days)

Visit 9 Month 6 (26 weeks +/- 30 days)

Visit 10 Month 12 (52 weeks +/- 30 days)

Visit 11 Month 18 (78 weeks +/- 45 days)

Visit 12 Month 23 (Minimum 4 weeks Prior to Month 24 Visit; 96 to 104 weeks)

Visit 13 Month 24 (104 weeks +/- 28 days)

Visit 14 Month 30 (130 weeks +/- 45 days)

Visit 15 Month 36 (156 weeks +/- 45 days)

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 12/24/2012 12/26/2012 Overdue/Received
one year report 06/25/2013 06/25/2013 On Time
18 month report 12/24/2013 01/27/2014 Overdue/Received
two year report 06/25/2014 06/17/2014 On Time
three year report 06/25/2015 06/24/2015 On Time
four year report 06/24/2016 06/22/2016 On Time
five year report 06/24/2017    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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