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RECRUITINGPhase 3INTERVENTIONAL

A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed. XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States. Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b) 1. That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated), and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt) 2. Uncontrolled by medical therapy (to meet out-of-US \[OUS\] requirements) with participants who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion b (and not a) will be enrolled in each cohort. Who Should NOT Join This Trial: - History of angle-closure glaucoma where the angle has not been surgically opened in the SE. - History of secondary open-angle glaucoma (e.g., neovascular, pigmentary, pseudoexfoliative, uveitic, angle recession/traumatic glaucoma, etc.) in the SE. - Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the SE. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b) 1. That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated), and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt) 2. Uncontrolled by medical therapy (to meet out-of-US \[OUS\] requirements) with participants who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion b (and not a) will be enrolled in each cohort. Exclusion Criteria: * History of angle-closure glaucoma where the angle has not been surgically opened in the SE. * History of secondary open-angle glaucoma (e.g., neovascular, pigmentary, pseudoexfoliative, uveitic, angle recession/traumatic glaucoma, etc.) in the SE. * Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the SE.

Treatments Being Tested

DEVICE

XEN63 Glaucoma Treatment System

Gel Stent

Locations (20)

Arizona Advanced Eye Research Institute /ID# 268363
Glendale, Arizona, United States
LA Glaucoma Group /ID# 268444
Culver City, California, United States
North Bay Eye Associates /ID# 277071
Petaluma, California, United States
University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, Colorado, United States
Colorado Eye Institute /ID# 277072
Colorado Springs, Colorado, United States
Brandon Eye Associates - Brandon /ID# 277074
Brandon, Florida, United States
New Vision Eye Center /ID# 269955
Vero Beach, Florida, United States
Coastal Research Associates - Roswell /ID# 268458
Roswell, Georgia, United States
Illinois Eye Center - Peoria Location /ID# 277127
Peoria, Illinois, United States
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451
Overland Park, Kansas, United States
Minnesota Eye Consultants - Minneapolis /ID# 272445
Minneapolis, Minnesota, United States
Vance Thompson Vision - Omaha /ID# 271599
Omaha, Nebraska, United States
Oklahoma Eye Surgeons /ID# 269174
Oklahoma City, Oklahoma, United States
Ophthalmic Partners of PA /ID# 276059
Bala-Cynwyd, Pennsylvania, United States
Wills Eye Hospital Glaucoma Dept /ID# 268569
Philadelphia, Pennsylvania, United States
Glaucoma Associates Of Texas /ID# 268745
Dallas, Texas, United States
UT Southwestern Medical Center /ID# 268571
Dallas, Texas, United States
El Paso Eye Surgeons /ID# 268356
El Paso, Texas, United States
Berkeley Eye Center - Houston Greenway Plaza /ID# 277078
Houston, Texas, United States
University of Virginia /ID# 277487
Charlottesville, Virginia, United States