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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

RecruitingPhase 3Ages 45 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 th

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • XEN63 Glaucoma Treatment System
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Where

29 sites
Arizona Advanced Eye Research Institute /ID# 268363
Glendale, United States
LA Glaucoma Group /ID# 268444
Culver City, United States
North Bay Eye Associates /ID# 277071
Petaluma, United States
University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, United States
Colorado Eye Institute /ID# 277072
Colorado Springs, United States
Brandon Eye Associates - Brandon /ID# 277074
Brandon, United States
East Coast Institute for Research /ID# 280411
Jacksonville, United States
New Vision Eye Center /ID# 269955
Vero Beach, United States

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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