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
Recruiting · NCT06822738 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Inclusion criteria
- Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b)
- 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)
- 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.
Where it is running
27 locations listed across 17 US states.
- 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
- East Coast Institute for Research /ID# 280411 - Jacksonville, 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
- Tulane University School of Medicine /ID# 277486 - New Orleans, Louisiana, United States
- Fraser Eye Care Center /ID# 281837 - Fraser, Michigan, United States
- Minnesota Eye Consultants - Minneapolis /ID# 272445 - Minneapolis, Minnesota, United States
- Vance Thompson Vision - Omaha /ID# 271599 - Omaha, Nebraska, United States
- Cincinnati Eye Institute /ID# 279773 - Cincinnati, Ohio, United States
- Cleveland Clinic - Cleveland /ID# 277070 - Cleveland, Ohio, 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 /ID# 268569 - Philadelphia, Pennsylvania, United States
- Glaucoma Associates Of Texas /ID# 268745 - Dallas, Texas, United States
- University of Texas - 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
- Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119 - Roanoke, Virginia, United States
- The Eye Centers of Racine and Kenosha /ID# 271266 - Kenosha, Wisconsin, United States