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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Arizona Advanced Eye Research Institute /ID# 268363
RECRUITING
Glendale
California
LA Glaucoma Group /ID# 268444
RECRUITING
Culver City
Colorado
University Of Colorado - Anschutz Medical Campus /ID# 269947
RECRUITING
Aurora
Florida
New Vision Eye Center /ID# 269955
RECRUITING
Vero Beach
Georgia
Coastal Research Associates - Roswell /ID# 268458
RECRUITING
Roswell
Kansas
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451
RECRUITING
Overland Park
Minnesota
Minnesota Eye Consultants - Minneapolis /ID# 272445
RECRUITING
Minneapolis
Nebraska
Vance Thompson Vision - Omaha /ID# 271599
RECRUITING
Omaha
Oklahoma
Oklahoma Eye Surgeons /ID# 269174
RECRUITING
Oklahoma City
Pennsylvania
Ophthalmic Partners of PA /ID# 276059
RECRUITING
Bala-cynwyd
Wills Eye Hospital Glaucoma Dept /ID# 268569
RECRUITING
Philadelphia
Texas
Glaucoma Associates Of Texas /ID# 268745
RECRUITING
Dallas
UT Southwestern Medical Center /ID# 268571
RECRUITING
Dallas
El Paso Eye Surgeons /ID# 268356
RECRUITING
El Paso
Virginia
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119
RECRUITING
Roanoke
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2028-11
Participants
Target number of participants: 130
Treatments
Experimental: XEN63 Ab Externo
Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months.
Experimental: XEN63 Ab Interno
Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov