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

NCT ID: NCT03654885

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-05-13

Brief Summary

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.

Detailed Description

This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN-45 to reduce intraocular pressure (IOP) and reduce the amount of topical IOP-lowering medications in participants poorly controlled on topical therapy. The planned study duration is 12 months. Participants were to be screened for enrollment and eligible candidates were to be approached to ascertain interest in study participation. Eligible participants were to be randomized 2:1; resulting in approximately 95 eyes implanted with XEN-45 and 44 eyes received trabeculetomy by study end.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XEN-45 Gel Stent

Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).

Group Type: ACTIVE_COMPARATOR

XEN-45 Gel Stent

Intervention Type: DEVICE

XEN-45 gel stent device implant

Trabeculectomy

Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).

Group Type: ACTIVE_COMPARATOR

Trabeculectomy

Intervention Type: PROCEDURE

Trabeculectomy surgery

Interventions

XEN-45 Gel Stent

XEN-45 gel stent device implant

Intervention Type: DEVICE

Trabeculectomy

Trabeculectomy surgery

Intervention Type: PROCEDURE

Eligibility 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 20/100 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

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

university of Pittsburgh /ID# 233622

Pittsburgh, Pennsylvania, United States

Carolinas Centers for Sight,PC /ID# 233606

Florence, South Carolina, United States

Nashville Vision Associates /ID# 233644

Nashville, Tennessee, United States

Glaucoma Associates of Texas /ID# 233587

Dallas, Texas, United States

El Paso Eye Surgeons, P.A. /ID# 233584

El Paso, Texas, United States

Houston Eye Associates /ID# 233621

Houston, Texas, United States

Baylor College of Medicine - Baylor Medical Center /ID# 233612

Houston, Texas, United States

Vistar Eye Center /ID# 233652

Roanoke, Virginia, United States

SSM Health Dean Medical Group /ID# 233624

Madison, Wisconsin, United States

The Eye Centers of Racine and Kenosha LTD /ID# 233657

Racine, Wisconsin, United States

Countries

United States

References

Sheybani A, Vera V, Grover DS, Vold SD, Cotter F, Bedrood S, Sawhney G, Piette SD, Simonyi S, Gu X, Balaram M, Gallardo MJ. Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months. Am J Ophthalmol. 2023 Aug;252:306-325. doi: 10.1016/j.ajo.2023.03.026. Epub 2023 Mar 25.

Reference Type: DERIVED

PMID: 36972738 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

CMO-US-EYE-0600

Identifier Type: -

Identifier Source: org_study_id