Open-Angle GlaucomaPhase 3NCT05411198
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 Phase 3 study testing XEN45 (Glaucoma Gel Stent) in people with Open-Angle Glaucoma, run by AbbVie at 25 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Open-Angle Glaucoma
- What is being tested?
- XEN45 (Glaucoma Gel Stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 22 Jul 2022to 4 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States23 sites
Vance Thompson Vision /ID# 261125
Alexandria, Minnesota, 56308-3408
Georgia Eye Partners /ID# 245203
Atlanta, Georgia, 30342
Ophthalmic Partners, PC /ID# 245367
Bala-Cynwyd, Pennsylvania, 19004
The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355
Bethesda, Maryland, 20817
Glaucoma Associates of Texas /ID# 227580
Dallas, Texas, 75231
University of Texas Southwestern Medical Center /ID# 246848
Dallas, Texas, 75390-7208
El Paso Eye Surgeons, P.A. /ID# 227575
El Paso, Texas, 79902
Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925
Falls Church, Virginia, 22042-3013
Vold Vision /ID# 245285
Fayetteville, Arkansas, 72704
East Coast Institute for Research /ID# 255508
Jacksonville, Florida, 32256-9680
Kremer Eye Center - King of Prussia /ID# 245573
King of Prussia, Pennsylvania, 19406
NYU Langone Medical Center /ID# 227583
New York, New York, 10016-6402
Fichte Endl & Elmer Eyecare /ID# 245165
Niagara Falls, New York, 14304
Oklahoma Eye Surgeons /ID# 246840
Oklahoma City, Oklahoma, 73112
Stiles Eyecare Excellence /ID# 227576
Overland Park, Kansas, 66213
UCLA Doheny Eye Center /ID# 227587
Pasadena, California, 91105
University of Utah /ID# 245324
Salt Lake City, Utah, 84112-5500
Eye associates /ID# 227572
San Antonio, Texas, 78229
Center for Sight - Sarasota /ID# 227577
Sarasota, Florida, 34239
Vance Thompson Vision /ID# 260892
Sioux Falls, South Dakota, 57108
Washington University-School of Medicine /ID# 245452
St Louis, Missouri, 63110
Ventura Ophthalmology /ID# 227585
Ventura, California, 93003
New Vision Eye Center /ID# 261053
Vero Beach, Florida, 32960-6551
Australia2 sites
Eye Surgery Associates /ID# 252207
East Melbourne, Victoria, 3002
Melbourne Eye Specialists /ID# 252353
Fitzroy, Victoria, VIC3065
About this study
Official title: 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.
Read more
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.
- Conditions
- Open-Angle Glaucoma
- Being tested
- XEN45 (Glaucoma Gel Stent)
- Keywords
- Open-Angle Glaucoma, Glaucoma, OAG, XEN45, Glaucoma Gel Stent, XEN45 Glaucoma Treatment System
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN45 (Glaucoma Gel Stent)Device
Ab externo implant
| Study group | Role | What they receive |
|---|---|---|
| XEN45 (Glaucoma Gel Stent) | Experimental | Participants will receive XEN45 implanted using an ab externo approach on Day 1. Receives: Device: XEN45 (Glaucoma Gel Stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start22 Jul 2022
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411198
- Sponsor's protocol ID
- 1924-703-007
- Status last verified
- Feb 2026
- First submitted
- 6 Jun 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent
- ClinicalTrials.gov ID
- NCT05411198
- Acronym / sponsor ID
- 1924-703-007
- Conditions
- Open-Angle Glaucoma
- Keywords
- Open-Angle Glaucoma, Glaucoma, OAG, XEN45, Glaucoma Gel Stent, XEN45 Glaucoma Treatment System
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XEN45 (Glaucoma Gel Stent) | Experimental | Device: XEN45 (Glaucoma Gel Stent)Participants will receive XEN45 implanted using an ab externo approach on Day 1. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Glaucoma in the study eye.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XEN45 (Glaucoma Gel Stent)Ab externo implant | Device | XEN45 (Glaucoma Gel Stent) |
Primary outcome
Percentage of Participants Achieving Effectiveness of XEN45
Time frame: Month 12
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XEN45 (Glaucoma Gel Stent) in people with Open-Angle Glaucoma, run by AbbVie at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Effectiveness of XEN45 (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.