XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Vold Vision, Fayetteville, Arkansas, 72704 | Status Not Available | |
Location Retina Institute of California, Arcadia, California, 91007 | Status Not Available | |
Location Angeles Eye Institute, Culver City, California, 90232 | Status Not Available | |
Location Cha Medical Group Pc, Los Angeles, California, 90027 | Status Not Available | |
Location Grutzmacher Lewis and Sierra Inc., Sacramento, California, 95815 | Status Not Available | |
Location University of Colorado Denver, Denver, Colorado, 80291-0238 | Status Not Available | |
Location Howard University Hospital, Washington, District of Columbia, 20060 | Status Not Available | |
Location Eye Surgery Associates, Hollywood, Florida, 33020 | Status Not Available | |
Location Specialty Retina Center, Weston, Florida, 33326 | Status Not Available | |
Location Georgia Eye Partners, Atlanta, Georgia, 30342 | Status Not Available | |
Location Coastal Research Associates, Roswell, Georgia, 30076 | Status Not Available | |
Location Tyrie Lee Jenkins MD Inc., Honolulu, Hawaii, 96814 | Status Not Available | |
Location Illinois Eye Center, Peoria, Illinois, 61615 | Status Not Available | |
Location Stiles Eyecare Excellence, Overland Park, Kansas, 66213 | Status Not Available | |
Location Advanced Glaucoma Specialists, Reading, Massachusetts, 01867 | Status Not Available | |
Location Kellogg Eye Center University of Michigan health system, Ann Arbor, Michigan, 48105 | Status Not Available | |
Location Mayo Clinic Jacksonville, Saint Paul, Minnesota, 55108 | Status Not Available | |
Location Washington University in St. Louis, Saint Louis, Missouri, 63110 | Status Not Available | |
Location Glaucoma associates/consultants of the capital region, Slingerlands, New York, 12159 | Status Not Available | |
Location Carolina Eye Associates, Southern Pines, North Carolina, 28387 | Status Not Available | |
Location Eye Care Associates Inc, Youngstown, Ohio, 44502 | Status Not Available | |
Location Dean McGee Eye Institute, Oklahoma City, Oklahoma, 73104 | Status Not Available | |
Location Ludwick Eye Center, Chambersburg, Pennsylvania, 17201 | Status Not Available | |
Location Kremer Eye Center, King Of Prussia, Pennsylvania, 19406 | Status Not Available | |
Location Wills Eye Institute, Philadelphia, Pennsylvania, 19107 | Status Not Available | |
Location university of Pittsburgh, Pittsburgh, Pennsylvania, 15213 | Status Not Available | |
Location Carolinas Centers for Sight,PC, Florence, South Carolina, 29501 | Status Not Available | |
Location Nashville Vision Associates, Nashville, Tennessee, 37205 | Status Not Available | |
Location Glaucoma Associates of Texas, Dallas, Texas, 75231 | Status Not Available | |
Location El Paso Eye Surgeons, P.A., El Paso, Texas, 79902 | Status Not Available | |
Location Houston Eye Associates, Houston, Texas, 77025 | Status Not Available | |
Location Baylor College of Medicine - Baylor Medical Center, Houston, Texas, 77030-3411 | Status Not Available | |
Location Vistar Eye Center, Roanoke, Virginia, 24011 | Status Not Available | |
Location SSM Health Dean Medical Group, Madison, Wisconsin, 53715 | Status Not Available | |
Location The Eye Centers of Racine and Kenosha LTD, Racine, Wisconsin, 53405 | Status Not Available |
The purpose of this study is to compare the safety and efficacy of XEN-45 to trabeculectomy in participants with open angle glaucoma refractory to topical medical therapy.
Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats
Time Frame: Baseline (Preoperative) to Month 12
Mean IOP Over Time
Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Change From Baseline in Mean IOP Over Time
Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Mean Number of Topical IOP-Lowering Medications Over Time
Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time
Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Change From Baseline in Mean IOP at Month 12
Time Frame: Baseline (Preoperative) and Month 12
Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12
Time Frame: Baseline (Preoperative) and Month 12
Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg
Time Frame: Baseline (Preoperative) and Month 12
Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg
Time Frame: Baseline (Preoperative) and Month 12
Percentage of Participants Achieving Specific IOP Targets at Month 12
Time Frame: Month 12
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12
Time Frame: Baseline (Preoperative) to Month 12
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12
Time Frame: Baseline (Preoperative) and Month 12
Percentage of Participants With Needlings Performed
Time Frame: Up to Month 12
Mean Number of Needlings Per Eye
Time Frame: Up to Month 12
Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings
Time Frame: Month 12
Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings
Time Frame: Month 12
Percentage of Participants With Antifibrotic Use During Needling
Time Frame: Up to Month 12
Percentage of Participants Achieving Complete Success at Month 12
Time Frame: Month 12
Percentage of Participants Achieving Qualified Success at Month 12
Time Frame: Month12
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye
Time Frame: Month 12
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes
Time Frame: Month 12
Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use
Time Frame: Month 12
Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration
Time Frame: Month 12
Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy
Time Frame: Month 12
Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy
Time Frame: Month 12
Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy
Time Frame: Month 12
Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy
Time Frame: Month 12
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses
Time Frame: Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12
Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale
Time Frame: Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12
Mean Surgically Induced Astigmatism - Autorefractor Reading
Time Frame: Month 12
Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading
Time Frame: Baseline (Preoperative) and Month 12
Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites
Time Frame: Baseline (Preoperative), Week 1, and Months 1 and 12
Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth
Time Frame: Baseline, Day 1 and Week 2
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D
Time Frame: Baseline, Day 1 and Week 2
Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites
Time Frame: Up to Month 12
Bleb Morphology - Slit Lamp Photography at Selected Sites
Time Frame: Up to Month 12
Percentage of Participants With Clinical Hypotony
Time Frame: Month 12
Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment
Time Frame: Up to Month 12
Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs)
Time Frame: Median follow-up of 366.0 days
Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs)
Time Frame: Median follow-up of 366.0 days
Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up
Time Frame: Baseline up to Month 12
Pachymetry Based on Change From Baseline In Average Central Corneal Thickness
Time Frame: Baseline (Preoperative) and Month 12
Change From Baseline in Visual Field Examinations Analyzed by Machine Type
Time Frame: Baseline and Month 12
Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs)
Time Frame: Median follow-up of 366.0 days
Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores
Time Frame: Baseline (Preoperative) to Month 6
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine
Time Frame: Month 3
PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health
Time Frame: Baseline (Preoperative) and Month 12
PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health
Time Frame: Baseline (Preoperative) and Month 12
Interventions:
- Device: XEN-45 Gel Stent
- Procedure: Trabeculectomy
Enrollment:
158
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