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

NCT03654885 | Completed Phase 4 Results FDA Device

• 1 other identifier: CMO-US-EYE-0600
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 35

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats

  IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.

  Baseline (Preoperative) to Month 12

Secondary Outcomes (47)

• Mean IOP Over Time

  Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12

• Change From Baseline in Mean IOP Over Time

  Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12

• Mean Number of Topical IOP-Lowering Medications Over Time

  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

  Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12

• Change From Baseline in Mean IOP at Month 12

  Baseline (Preoperative) and Month 12

Study Arms (2)

XEN-45 Gel Stent

ACTIVE COMPARATOR

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

Device: XEN-45 Gel Stent

Trabeculectomy

ACTIVE COMPARATOR

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).

Procedure: Trabeculectomy

Interventions

XEN-45 Gel Stent DEVICE

XEN-45 gel stent device implant

XEN-45 Gel Stent

Trabeculectomy PROCEDURE

Trabeculectomy surgery

Trabeculectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (35)

Vold Vision /ID# 233677

Fayetteville, Arkansas, 72704, United States

Location

Retina Institute of California /ID# 233692

Arcadia, California, 91007, United States

Location

Angeles Eye Institute /ID# 233632

Culver City, California, 90232, United States

Location

Cha Medical Group Pc /Id# 233649

Los Angeles, California, 90027, United States

Location

Grutzmacher Lewis and Sierra Inc. /ID# 233654

Sacramento, California, 95815, United States

Location

University of Colorado Denver /ID# 233676

Denver, Colorado, 80291-0238, United States

Location

Howard University Hospital /ID# 233615

Washington D.C., District of Columbia, 20060, United States

Location

Eye Surgery Associates /ID# 233638

Hollywood, Florida, 33020, United States

Location

Specialty Retina Center /ID# 233628

Weston, Florida, 33326, United States

Location

Georgia Eye Partners /ID# 233655

Atlanta, Georgia, 30342, United States

Location

Coastal Research Associates /ID# 233575

Roswell, Georgia, 30076, United States

Location

Tyrie Lee Jenkins MD Inc. /ID# 233674

Honolulu, Hawaii, 96814, United States

Location

Illinois Eye Center /ID# 233631

Peoria, Illinois, 61615, United States

Location

Stiles Eyecare Excellence /ID# 233583

Overland Park, Kansas, 66213, United States

Location

Advanced Glaucoma Specialists /ID# 233690

Reading, Massachusetts, 01867, United States

Location

Kellogg Eye Center University of Michigan health system /ID# 233651

Ann Arbor, Michigan, 48105, United States

Location

Mayo Clinic Jacksonville /ID# 233634

Saint Paul, Minnesota, 55108, United States

Location

Washington University in St. Louis /ID# 233599

St Louis, Missouri, 63110, United States

Location

Glaucoma associates/consultants of the capital region /ID# 233695

Slingerlands, New York, 12159, United States

Location

Carolina Eye Associates /ID# 233656

Southern Pines, North Carolina, 28387, United States

Location

Eye Care Associates Inc /ID# 233636

Youngstown, Ohio, 44502, United States

Location

Dean McGee Eye Institute /ID# 233595

Oklahoma City, Oklahoma, 73104, United States

Location

Ludwick Eye Center /ID# 233691

Chambersburg, Pennsylvania, 17201, United States

Location

Kremer Eye Center /Id# 233642

King of Prussia, Pennsylvania, 19406, United States

Location

Wills Eye Institute /ID# 233645

Philadelphia, Pennsylvania, 19107, United States

Location

university of Pittsburgh /ID# 233622

Pittsburgh, Pennsylvania, 15213, United States

Location

Carolinas Centers for Sight,PC /ID# 233606

Florence, South Carolina, 29501, United States

Location

Nashville Vision Associates /ID# 233644

Nashville, Tennessee, 37205, United States

Location

Glaucoma Associates of Texas /ID# 233587

Dallas, Texas, 75231, United States

Location

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

El Paso, Texas, 79902, United States

Location

Houston Eye Associates /ID# 233621

Houston, Texas, 77025, United States

Location

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

Houston, Texas, 77030-3411, United States

Location

Vistar Eye Center /ID# 233652

Roanoke, Virginia, 24011, United States

Location

SSM Health Dean Medical Group /ID# 233624

Madison, Wisconsin, 53715, United States

Location

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

Racine, Wisconsin, 53405, United States

Location

Related Publications (1)

• 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.

  PMID: 36972738 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: May 13, 2021
• Study Completion: May 13, 2021
• Last Updated: July 21, 2022
• Results First Posted: July 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

US (35)