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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P080030 / PAS002 |
| Date Original Protocol Accepted |
06/25/2012
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| Date Current Protocol Accepted |
05/13/2016
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| Study Name |
New Enrollment Study
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| Device Name |
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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
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| Study Population |
Males or Females, 22 years of age or older
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| 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%.
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| Key Study Endpoints |
The primary endpoints will be the occurrence of STAEs. The STAEs include best corrected visual acuity (BCVA) loss greater than or equal to 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 greater than or equal to 10 mmHg at any time postoperative, and loss of best spectacle corrected visual acuity of greater than or equal to 2 lines (greater than or equal to 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 greater than or equal to 20% vs. baseline IOP without ocular hypotensive medication, and mean diurnal IOP less than or equal to 18 mmHg without ocular hypotensive medication, at 24 months. The rate of these effectiveness outcomes will be compared between the treatment and control groups.
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| 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)
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