Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
AbbVie
Study ID
NCT05411198
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • XEN45 (Glaucoma Gel Stent) — DEVICE
    Ab externo implant

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 externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States. All participants will receive XEN45 implanted using 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
Jul 22, 2022
Status verified
Feb 2026
Primary completion
Feb 4, 2026
Completion
Feb 4, 2026

Study Design

Enrollment
74 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XEN45 (Glaucoma Gel Stent)
    Participants will receive XEN45 implanted using an ab externo approach on Day 1.

Primary Outcome Measure

Percentage of Participants Achieving Effectiveness of XEN45 [ Time Frame: Month 12 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Vold Vision /ID# 245285FayettevilleArkansas72704-
UCLA Doheny Eye Center /ID# 227587PasadenaCalifornia91105-
Ventura Ophthalmology /ID# 227585VenturaCalifornia93003-
East Coast Institute for Research /ID# 255508JacksonvilleFlorida32256-9680-
Center for Sight - Sarasota /ID# 227577SarasotaFlorida34239-
New Vision Eye Center /ID# 261053Vero BeachFlorida32960-6551-
Georgia Eye Partners /ID# 245203AtlantaGeorgia30342-
Stiles Eyecare Excellence /ID# 227576Overland ParkKansas66213-
The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355BethesdaMaryland20817-
Vance Thompson Vision /ID# 261125AlexandriaMinnesota56308-3408-
Washington University-School of Medicine /ID# 245452St LouisMissouri63110-
NYU Langone Medical Center /ID# 227583New YorkNew York10016-6402-
Fichte Endl & Elmer Eyecare /ID# 245165Niagara FallsNew York14304-
Oklahoma Eye Surgeons /ID# 246840Oklahoma CityOklahoma73112-
Ophthalmic Partners, PC /ID# 245367Bala-CynwydPennsylvania19004-
Kremer Eye Center - King of Prussia /ID# 245573King of PrussiaPennsylvania19406-
Vance Thompson Vision /ID# 260892Sioux FallsSouth Dakota57108-
Glaucoma Associates of Texas /ID# 227580DallasTexas75231-
University of Texas Southwestern Medical Center /ID# 246848DallasTexas75390-7208-
El Paso Eye Surgeons, P.A. /ID# 227575El PasoTexas79902-
Eye associates /ID# 227572San AntonioTexas78229-
University of Utah /ID# 245324Salt Lake CityUtah84112-5500-
Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925Falls ChurchVirginia22042-3013-

Find similar trials in Fayetteville, AR

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Vold Vision· Fayetteville, ARUCLA Doheny Eye Center· Pasadena, CAVentura Ophthalmology· Ventura, CAEast Coast Institute for Research· Jacksonville, FLCenter for Sight - Sarasota· Sarasota, FLNew Vision Eye Center· Vero Beach, FL

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