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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
AbbVie
Study ID
NCT06822738
Phase
PHASE3
Status
Recruiting
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Conditions

  • Primary Open Angle Glaucoma

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XEN63 Glaucoma Treatment System — DEVICE
    Gel Stent

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percentage of Participants With Treatment Response of Achieving ≥ 20% Reduction in Intraocular Pressure (IOP) From Baseline on the Same or Fewer Number of IOP-Lowering Medications Compared to Baseline [ Time Frame: Month 12 ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Arizona Advanced Eye Research Institute /ID# 268363GlendaleArizona85306-
LA Glaucoma Group /ID# 268444Culver CityCalifornia90232-
North Bay Eye Associates /ID# 277071PetalumaCalifornia94954-
University Of Colorado - Anschutz Medical Campus /ID# 269947AuroraColorado80045-
Colorado Eye Institute /ID# 277072Colorado SpringsColorado80924-
Eye Center of Northern Colorado /ID# 281798Fort CollinsColorado80528-
Brandon Eye Associates - Brandon /ID# 277074BrandonFlorida33511-
New Vision Eye Center /ID# 269955Vero BeachFlorida32960-
Coastal Research Associates - Roswell /ID# 268458RoswellGeorgia30076-
Illinois Eye Center - Peoria Location /ID# 277127PeoriaIllinois61615-
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451Overland ParkKansas66213-
Tulane Center for Clinical Research /ID# 277486New OrleansLouisiana70112-2703-
Minnesota Eye Consultants - Minneapolis /ID# 272445MinneapolisMinnesota55431-
Vance Thompson Vision - Omaha /ID# 271599OmahaNebraska68137-
Oklahoma Eye Surgeons /ID# 269174Oklahoma CityOklahoma73112-
Ophthalmic Partners of PA /ID# 276059Bala-CynwydPennsylvania19004-
Wills Eye Hospital /ID# 268569PhiladelphiaPennsylvania19107-
Glaucoma Associates Of Texas /ID# 268745DallasTexas75231-
UT Southwestern Medical Center /ID# 268571DallasTexas75390
Site Coordinator
214-645-2014
El Paso Eye Surgeons /ID# 268356El PasoTexas79902-
Berkeley Eye Center - Houston Greenway Plaza /ID# 277078HoustonTexas77027-
University of Virginia /ID# 277487CharlottesvilleVirginia22908-
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119RoanokeVirginia24016-
The Eye Centers of Racine and Kenosha LTD /ID# 271266RacineWisconsin53405-

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By research site
Arizona Advanced Eye Research Institute· Glendale, AZLA Glaucoma Group· Culver City, CANorth Bay Eye Associates· Petaluma, CAUniversity Of Colorado - Anschutz Medical Campus· Aurora, COColorado Eye Institute· Colorado Springs, COEye Center of Northern Colorado· Fort Collins, CO

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