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

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent

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.

Study Overview

• Status: Recruiting
• Conditions: Open-Angle Glaucoma
• Intervention / Treatment: Device: XEN45 (Glaucoma Gel Stent)

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Eye Surgery Associates /ID# 252207
      • Contact: Site Coordinator; Phone Number: +61399988337
    • Fitzroy, Victoria, Australia, VIC3065
      • Recruiting
      • Melbourne Eye Specialists /ID# 252353
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Recruiting
      • Vold Vision /ID# 245285
  • California
    • Pasadena, California, United States, 91105
      • Recruiting
      • UCLA Doheny Eye Center /ID# 227587
    • Ventura, California, United States, 93003
      • Recruiting
      • Ventura Ophthalmology /ID# 227585
  • Florida
    • Jacksonville, Florida, United States, 32256-9680
      • Recruiting
      • East Coast Institute for Research /ID# 255508
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Center for Sight - Sarasota /ID# 227577
    • Vero Beach, Florida, United States, 32960-6551
      • Recruiting
      • New Vision Eye Center /ID# 261053
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Completed
      • Georgia Eye Partners /ID# 245203
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Recruiting
      • Stiles Eyecare Excellence /ID# 227576
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Johns Hopkins /ID# 245355
  • Minnesota
    • Alexandria, Minnesota, United States, 56308-3408
      • Recruiting
      • Vance Thompson Vision /ID# 261125
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University-School of Medicine /ID# 245452
  • New York
    • New York, New York, United States, 10017
      • Recruiting
      • New York University, Langone Health /ID# 227583
    • Niagara Falls, New York, United States, 14304
      • Recruiting
      • Fichte Endl & Elmer Eyecare Ophthalmology PC /ID# 245165
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Oklahoma Eye Surgeons /ID# 246840
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • Ophthalmic Partners, PC /ID# 245367
      • Contact: Site Coordinator; Phone Number: 484-434-2706
    • King Of Prussia, Pennsylvania, United States, 19406
      • Completed
      • Kremer Eye Center - King of Prussia /ID# 245573
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Vance Thompson Vision /ID# 260892
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • Recruiting
      • University of Texas Southwestern Medical Center /ID# 246848
    • Dallas, Texas, United States, 75231
      • Completed
      • Glaucoma Associates of Texas /ID# 227580
    • El Paso, Texas, United States, 79902
      • Recruiting
      • El Paso Eye Surgeons, P.A. /ID# 227575
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Eye associates /ID# 227572
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • Recruiting
      • University of Utah /ID# 245324
  • Virginia
    • Falls Church, Virginia, United States, 22042-3013
      • Recruiting
      • Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925
      • Contact: Site Coordinator; Phone Number: 703-534-3900, ext 5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Glaucoma in the study eye.

  1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy

  2. Study eye that meet at least one of the following criteria:

     • Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled)
     • Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
     • Have neovascular glaucoma
     • Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (OAG).

     Note: To allow for a subgroup of participants who only have OAG uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled.

     Exclusion Criteria:

• A lack of healthy conjunctiva showing free mobility (free of scarring or evidence of prior surgery) in the target area.
• Excessive intraoperative bleeding, such that visualization in the study eye is impaired.
• Any anatomy or finding in the study eye that limits the investigator's ability to visualize the anterior chamber, angle, or target area of the conjunctiva.
• Other surgical complication that in the opinion of the investigator could impede proper placement of the Gel Stent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XEN45 (Glaucoma Gel Stent); Participants will receive XEN45 implanted using an ab externo approach on Day 1.	Device: XEN45 (Glaucoma Gel Stent); Ab externo implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Effectiveness of XEN45	Effectiveness is defined as achieving 20% or more reduction of intraocular pressure (IOP) from baseline and on the same or fewer number of glaucoma medications than at baseline without secondary surgical intervention for IOP (SSII).	Month 12

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): August 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Open-Angle Glaucoma; Glaucoma; OAG; XEN45; Glaucoma Gel Stent; XEN45 Glaucoma Treatment System
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 1924-703-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes