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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:October 1, 2018
End Date:March 31, 2021
Contact:Clinical Trials Registry Team
Email:IR‐CTRegistration@Allergan.com
Phone:877‐277‐8566

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XEN45 Gel Stent Versus Trabeculectomy in Open-angle Glaucoma

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

This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to
evaluate the ability of XEN to reduce IOP and reduce the amount of topical IOP-lowering
medications in subjects poorly controlled on topical therapy. Patients will be randomized
2:1, resulting in approximately 190 eyes being implanted with XEN and approximately 95 eyes
will be receiving trabeculectomy. Subjects will be screened for enrollment and eligible
candidates will be approached to ascertain interest in study participation. Study duration
will be approximately 12 months.

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
We found this trial at
34
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Ann Arbor, Michigan 48105
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Atlanta, Georgia 30342
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Aurora, Colorado 80045
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Chambersburg, Pennsylvania 17201
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Columbia, Missouri 65202
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Dallas, Texas 75231
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El Paso, Texas 79902
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Fayetteville, Arkansas 72704
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Honolulu, Hawaii 96814
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Houston, TX
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La Jolla, California 92093
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Madison, Wisconsin 53715
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Madison, Wisconsin 53715
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Melbourne, Florida 32935
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Memphis, Tennessee 38103
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Peoria, Illinois 61615
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Philadelphia, Pennsylvania 19107
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Plantation, Florida 33322
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Poland, Ohio 44514
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Pompano Beach, Florida 33060
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Racine, Wisconsin 53405
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Reading, Massachusetts 01867
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Roswell, Georgia 30076
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Sacramento, California 95815
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Sandy Springs, Georgia 30328
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Slingerlands, New York 12159
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Southern Pines, North Carolina 28387
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Southfield, Michigan 48034
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Washington, District of Columbia 20060
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