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

Completed · Phase 4

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT03654885

Run by

Allergan

People needed

158

Starts

2018-10-01

Expected to finish

2021-05-13

Last updated by the study team

2022-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 20/100 or better
• Visual field mean deviation no worse than -18.0 decibels (dB)
• Medicated IOP ≥15 millimeter of mercury (mm Hg) and ≤44 mm Hg
• Participants not anticipated to require any ocular surgery (e.g., cataract surgery) in either eye up to 3 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 micro invasive glaucoma surgery (MIGS) procedures (such as i-Stent, gonioscopy-assisted transluminal trabeculotomy [GATT], Ab-interno canaloplasty [ABiC], Kahook dual blade goniotomy, etc.) are allowed ≥3 months before enrollment. CyPass® Micro-Stents were not allowed.

You may not qualify if…

• Participant has active neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
• Participant 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, ultrasound circular cyclocoagulation [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 ≤490 micrometer (μm) or ≥620μm
• Vitreous present in the anterior chamber
• Aphakic
• Participant 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, anterior chamber intraocular lens [ACIOL], perhaps sutured intraocular lens [IOL] or scleral fixated IOL, prior cystoid macular edema [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, iridocorneal endothelial syndrome [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

Where it is running

• Vold Vision /ID# 233677 — Fayetteville, Arkansas, United States
• Retina Institute of California /ID# 233692 — Arcadia, California, United States
• Angeles Eye Institute /ID# 233632 — Culver City, California, United States
• Cha Medical Group Pc /Id# 233649 — Los Angeles, California, United States
• Grutzmacher Lewis and Sierra Inc. /ID# 233654 — Sacramento, California, United States
• University of Colorado Denver /ID# 233676 — Denver, Colorado, United States
• Howard University Hospital /ID# 233615 — Washington D.C., District of Columbia, United States
• Eye Surgery Associates /ID# 233638 — Hollywood, Florida, United States
• Specialty Retina Center /ID# 233628 — Weston, Florida, United States
• Georgia Eye Partners /ID# 233655 — Atlanta, Georgia, United States
• Coastal Research Associates /ID# 233575 — Roswell, Georgia, United States
• Tyrie Lee Jenkins MD Inc. /ID# 233674 — Honolulu, Hawaii, United States
• Illinois Eye Center /ID# 233631 — Peoria, Illinois, United States
• Stiles Eyecare Excellence /ID# 233583 — Overland Park, Kansas, United States
• Advanced Glaucoma Specialists /ID# 233690 — Reading, Massachusetts, United States
• Kellogg Eye Center University of Michigan health system /ID# 233651 — Ann Arbor, Michigan, United States
• Mayo Clinic Jacksonville /ID# 233634 — Saint Paul, Minnesota, United States
• Washington University in St. Louis /ID# 233599 — St Louis, Missouri, United States
• Glaucoma associates/consultants of the capital region /ID# 233695 — Slingerlands, New York, United States
• Carolina Eye Associates /ID# 233656 — Southern Pines, North Carolina, United States
• Eye Care Associates Inc /ID# 233636 — Youngstown, Ohio, United States
• Dean McGee Eye Institute /ID# 233595 — Oklahoma City, Oklahoma, United States
• Ludwick Eye Center /ID# 233691 — Chambersburg, Pennsylvania, United States
• Kremer Eye Center /Id# 233642 — King of Prussia, Pennsylvania, United States
• Wills Eye Institute /ID# 233645 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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