Primary Open Angle GlaucomaPhase 3NCT06822738
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
A Phase 3 study testing XEN63 Glaucoma Treatment System in people with Primary Open Angle Glaucoma, run by AbbVie at 29 sites in United States.
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 interno (inside the eye) and ab externo (outside the eye) 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
- Primary Open Angle Glaucoma
- What is being tested?
- XEN63 Glaucoma Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 29 sitesUnited States
- Study dates
- 11 Feb 2025to Nov 2028
- Phase
- Phase 3
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
- Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b)
- That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated), and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt)
- Uncontrolled by medical therapy (to meet out-of-US [OUS] requirements) with participants who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion b (and not a) will be enrolled in each cohort.
Who cannot join
- History of angle-closure glaucoma where the angle has not been surgically opened in the SE.
- History of secondary open-angle glaucoma (e.g., neovascular, pigmentary, pseudoexfoliative, uveitic, angle recession/traumatic glaucoma, etc.) in the SE.
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the SE.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
United States29 sites, 25 recruiting
- Recruiting
University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, Colorado, 80045
- Recruiting
Ophthalmic Partners of PA /ID# 276059
Bala-Cynwyd, Pennsylvania, 19004
- Recruiting
Brandon Eye Associates - Brandon /ID# 277074
Brandon, Florida, 33511
- Recruiting
University of Virginia /ID# 277487
Charlottesville, Virginia, 22908
- Recruiting
Cincinnati Eye Institute /ID# 279773
Cincinnati, Ohio, 45242
- Recruiting
Cleveland Clinic - Cleveland /ID# 277070
Cleveland, Ohio, 44195
- Recruiting
Colorado Eye Institute /ID# 277072
Colorado Springs, Colorado, 80924
- Recruiting
LA Glaucoma Group /ID# 268444
Culver City, California, 90232
- Recruiting
Glaucoma Associates Of Texas /ID# 268745
Dallas, Texas, 75231
- Recruiting
University of Texas - Southwestern Medical Center /ID# 268571
Dallas, Texas, 75235
- Recruiting
El Paso Eye Surgeons /ID# 268356
El Paso, Texas, 79902
- Recruiting
Fraser Eye Care Center /ID# 281837
Fraser, Michigan, 48026
- Recruiting
Arizona Advanced Eye Research Institute /ID# 268363
Glendale, Arizona, 85306
- Recruiting
Berkeley Eye Center - Houston Greenway Plaza /ID# 277078
Houston, Texas, 77027
- Recruiting
East Coast Institute for Research /ID# 280411
Jacksonville, Florida, 32256
- Recruiting
The Eye Centers of Racine and Kenosha /ID# 271266
Kenosha, Wisconsin, 53142
- Recruiting
Minnesota Eye Consultants - Minneapolis /ID# 272445
Minneapolis, Minnesota, 55431
- Recruiting
Tulane University School of Medicine /ID# 277486
New Orleans, Louisiana, 70112
- Recruiting
NYC Glaucoma /ID# 283103
New York, New York, 10003
- Recruiting
Oklahoma Eye Surgeons /ID# 269174
Oklahoma City, Oklahoma, 73112
- Recruiting
Vance Thompson Vision - Omaha /ID# 271599
Omaha, Nebraska, 68137
- Completed
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451
Overland Park, Kansas, 66213
- Completed
Illinois Eye Center - Peoria Location /ID# 277127
Peoria, Illinois, 61615
- Recruiting
North Bay Eye Associates /ID# 277071
Petaluma, California, 94954
- Recruiting
Wills Eye Hospital /ID# 268569
Philadelphia, Pennsylvania, 19107
- Recruiting
Advanced Glaucoma Specialists /ID# 281858
Reading, Massachusetts, 01867
- Completed
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119
Roanoke, Virginia, 24016
- Recruiting
Coastal Research Associates - Roswell /ID# 268458
Roswell, Georgia, 30076
- Completed
New Vision Eye Center /ID# 269955
Vero Beach, Florida, 32960
About this study
Official title: A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma
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.
Read more
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.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- XEN63 Glaucoma Treatment System
- Keywords
- Primary Open Angle Glaucoma, AGN-9003
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN63 Glaucoma Treatment SystemDevice
Gel Stent
| Study group | Role | What they receive |
|---|---|---|
| XEN63 Ab Externo | Experimental | Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months. Receives: Device: XEN63 Glaucoma Treatment System |
| XEN63 Ab Interno | Experimental | Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months. Receives: Device: XEN63 Glaucoma Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
IOP is a measurement of the fluid pressure inside the study eye. Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications.
Measured: Month 12
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Month 12
Secondary outcomes (4)
Mean Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye at Month 12.
Measured: Month 12
Change From Baseline in Diurnal IOP
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Measured: Baseline to Month 12
Change from Baseline in Number of Topical IOP-Lowering Medications
A numerical count by class of drug of topical IOP lowering medications being taken.
Measured: Baseline to Month 12
Mean Number of Topical IOP-Lowering Medications
A numerical count by class of drug of topical IOP lowering medications being taken.
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 posted12 Feb 2025
- Study start11 Feb 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
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
- NCT06822738
- Sponsor's protocol ID
- M22-087
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2025
- Last updated
- 9 Oct 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.