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XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

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ClinicalTrials.gov Identifier: NCT03654885
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The aim of this study is to compare the effectiveness and safety of XEN to trabeculectomy in subjects with open angle glaucoma refractory to topical medical therapy

Condition or disease Intervention/treatment
Glaucoma Device: XEN group Device: Trabeculectory

Study Type : Observational
Estimated Enrollment : 286 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: XENTRAB: XEN45 Gel Stent Versus Trabeculectomy in Open-angle Glaucoma
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
XEN group
Subjects will undergo at least one preoperative visit (and more as needed), and then be scheduled for XEN implantation
Device: XEN group
Subjects will undergo at least one preoperative visit (and more as needed), and then be scheduled for XEN implantation

Trabeculectomy
Subjects will undergo at least one preoperative visit (and more as needed), and then be scheduled for trabeculectomy.
Device: Trabeculectory
Subjects will undergo at least one preoperative visit (and more as needed), and then be scheduled for trabeculectomy.




Primary Outcome Measures :
  1. Percentage of subjects achieving at least 20% mean Intraocular pressure (IOP) change from baseline on the same or fewer number of IOP-lowering medications [ Time Frame: Baseline, Month 12 ]

Secondary Outcome Measures :
  1. Change from baseline (medicated) in mean Intraocular pressure (IOP) [ Time Frame: Baseline, Month 12 ]
  2. Change from baseline (medicated)in mean number of topical IOP-lowering medications [ Time Frame: Baseline, Month 12 ]
  3. Proportion of eyes achieving specific IOP targets (≤18 mmHg, ≤17 mmHg, ≤16 mmHg, ≤15 mmHg, ≤14 mmHg, ≤13 mmHg, ≤12 mmHg [ Time Frame: Month 12 ]
  4. Proportion of eyes achieving at least 20% IOP reductions and specific IOP targets on same or lower number of topical IOP-lowering medications [ Time Frame: Month 12 ]
  5. proportion of eyes achieving at least 20% reduction of needling rates, number of needlings per eye, outcomes post needling, antifibrotics, including mean IOP and number of medications measured [ Time Frame: Month 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include subjects with OAG poorly controlled on topical therapy or who have failed prior SLT or MIGS surgeries who meet the inclusion and exclusion criteria
Criteria

Inclusion Criteria:

  • Open-angle glaucoma where the Intraocular pressure (IOP) is not controlled when using topical IOP-lowering glaucoma medication
  • Best-corrected baseline Snellen visual acuity of 20/80 or better
  • Visual field mean deviation no worse than -15.0 dB
  • Medicated IOP ≥18 mmHg and ≤44 mmHg
  • Subjects not anticipated to require any ocular surgery (e.g., cataract surgery) in either eye up to 12 months from the time of inclusion
  • Area of healthy, free, and mobile conjunctiva in the target area (superior bulbar conjunctiva)
  • Trabecular meshwork must be visible (with Shaffer angle grade ≥2 in the target quadrant)
  • Failed ab-interno canal or suprachoroidal MIGS procedures (such as i-Stent, CyPass, GATT, ABiC, Kahook dual blade goniotomy, etc.) are allowed.

Exclusion Criteria:

  • Subject has active neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
  • Subject has had prior ab externo incisional glaucoma surgery (such as trabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.), conjunctival filtering surgery, transscleral cycloablative procedures (such as cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy, UC3, etc.) or prior major conjunctival surgery (i.e., scleral buckle)

    -. Clinically significant inflammation or infection within 30 days before the preoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease, keratitis, uveitis, herpes simplex infection)

  • Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target area
  • History of corneal surgery, corneal opacities, or corneal disease
  • Central corneal thickness ≤490μm or ≥620μm
  • Vitreous present in the anterior chamber
  • Aphakic
  • Subject has had prior intraocular surgery in either eye within ≤3 months before the preoperative visit (including phacoemulsification)
  • History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreous loss, ACIOL, perhaps sutured IOL or scleral fixated IOL, prior CME, etc.)
  • Presence of intraocular silicone oil
  • Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or other ophthalmic disease or disorder that could confound study results or impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger, ICE, etc.
  • Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., bovine or porcine products, or glutaraldehyde)
  • Pregnant or nursing women and those planning a pregnancy during the study period.
  • Participation in another drug or device clinical trial concluding within 30 days before the preoperative visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654885


Contacts
Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

Locations
United States, Arkansas
Vold Vision Not yet recruiting
Fayetteville, Arkansas, United States, 72704
United States, California
Sacramento Eye Consultants Not yet recruiting
Sacramento, California, United States, 95815
United States, Colorado
UC Health Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Georgia
Coastal Research Associates, LLC Recruiting
Roswell, Georgia, United States, 30076
022 Not yet recruiting
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Illinois Eye Center Not yet recruiting
Peoria, Illinois, United States, 61615
United States, Kansas
Stiles Eyecare Excellence Glaucoma Institute Not yet recruiting
Overland Park, Kansas, United States, 66213
United States, Michigan
Kellogg Eye Center Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Glaucoma Center of Michigan Not yet recruiting
Southfield, Michigan, United States, 48034
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Glaucoma Associates ot the Captiol Region Not yet recruiting
Slingerlands, New York, United States, 12159
United States, North Carolina
Carolina Eye Associates Not yet recruiting
Southern Pines, North Carolina, United States, 28387
United States, Ohio
Eye Care Associates Not yet recruiting
Poland, Ohio, United States, 44514
United States, Pennsylvania
Ludwick Eye Center Not yet recruiting
Chambersburg, Pennsylvania, United States, 17201
Wills Eye Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Hamilton Eye Institute Not yet recruiting
Memphis, Tennessee, United States, 38103
United States, Texas
Glaucoma Associates of Texas Not yet recruiting
Dallas, Texas, United States, 75231
El Paso Eye Surgeons, PA Recruiting
El Paso, Texas, United States, 79902
United States, Wisconsin
Eye Center of Racine and Kenosha Not yet recruiting
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
Allergan
Investigators
Study Director: Mini Balaram, MD Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03654885     History of Changes
Other Study ID Numbers: CMO-US-EYE-0600
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases