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
1 other identifier
interventional
74
2 countries
25
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2022
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2026
CompletedFebruary 27, 2026
February 1, 2026
3.5 years
June 6, 2022
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
XEN45 (Glaucoma Gel Stent)
EXPERIMENTALParticipants will receive XEN45 implanted using an ab externo approach on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Glaucoma in the study eye.
- Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (25)
Vold Vision /ID# 245285
Fayetteville, Arkansas, 72704, United States
UCLA Doheny Eye Center /ID# 227587
Pasadena, California, 91105, United States
Ventura Ophthalmology /ID# 227585
Ventura, California, 93003, United States
East Coast Institute for Research /ID# 255508
Jacksonville, Florida, 32256-9680, United States
Center for Sight - Sarasota /ID# 227577
Sarasota, Florida, 34239, United States
New Vision Eye Center /ID# 261053
Vero Beach, Florida, 32960-6551, United States
Georgia Eye Partners /ID# 245203
Atlanta, Georgia, 30342, United States
Stiles Eyecare Excellence /ID# 227576
Overland Park, Kansas, 66213, United States
The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355
Bethesda, Maryland, 20817, United States
Vance Thompson Vision /ID# 261125
Alexandria, Minnesota, 56308-3408, United States
Washington University-School of Medicine /ID# 245452
St Louis, Missouri, 63110, United States
NYU Langone Medical Center /ID# 227583
New York, New York, 10016-6402, United States
Fichte Endl & Elmer Eyecare /ID# 245165
Niagara Falls, New York, 14304, United States
Oklahoma Eye Surgeons /ID# 246840
Oklahoma City, Oklahoma, 73112, United States
Ophthalmic Partners, PC /ID# 245367
Bala-Cynwyd, Pennsylvania, 19004, United States
Kremer Eye Center - King of Prussia /ID# 245573
King of Prussia, Pennsylvania, 19406, United States
Vance Thompson Vision /ID# 260892
Sioux Falls, South Dakota, 57108, United States
Glaucoma Associates of Texas /ID# 227580
Dallas, Texas, 75231, United States
University of Texas Southwestern Medical Center /ID# 246848
Dallas, Texas, 75390-7208, United States
El Paso Eye Surgeons, P.A. /ID# 227575
El Paso, Texas, 79902, United States
Eye associates /ID# 227572
San Antonio, Texas, 78229, United States
University of Utah /ID# 245324
Salt Lake City, Utah, 84112-5500, United States
Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925
Falls Church, Virginia, 22042-3013, United States
Eye Surgery Associates /ID# 252207
East Melbourne, Victoria, 3002, Australia
Melbourne Eye Specialists /ID# 252353
Fitzroy, Victoria, VIC3065, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 9, 2022
Study Start
July 22, 2022
Primary Completion
February 4, 2026
Study Completion
February 4, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.