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 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
1 other identifier
interventional
130
1 country
21
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 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2025
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2025
CompletedStudy Start
First participant enrolled
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
March 20, 2026
March 1, 2026
3.7 years
February 7, 2025
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Month 12
Secondary Outcomes (4)
Mean Diurnal IOP
Month 12
Change From Baseline in Diurnal IOP
Baseline to Month 12
Change from Baseline in Number of Topical IOP-Lowering Medications
Baseline to Month 12
Mean Number of Topical IOP-Lowering Medications
Month 12
Study Arms (2)
XEN63 Ab Externo
EXPERIMENTALParticipants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months.
XEN63 Ab Interno
EXPERIMENTALParticipants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (21)
Arizona Advanced Eye Research Institute /ID# 268363
Glendale, Arizona, 85306, United States
LA Glaucoma Group /ID# 268444
Culver City, California, 90232, United States
North Bay Eye Associates /ID# 277071
Petaluma, California, 94954, United States
University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, Colorado, 80045, United States
Colorado Eye Institute /ID# 277072
Colorado Springs, Colorado, 80924, United States
Brandon Eye Associates - Brandon /ID# 277074
Brandon, Florida, 33511, United States
New Vision Eye Center /ID# 269955
Vero Beach, Florida, 32960, United States
Coastal Research Associates - Roswell /ID# 268458
Roswell, Georgia, 30076, United States
Illinois Eye Center - Peoria Location /ID# 277127
Peoria, Illinois, 61615, United States
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451
Overland Park, Kansas, 66213, United States
Minnesota Eye Consultants - Minneapolis /ID# 272445
Minneapolis, Minnesota, 55431, United States
Vance Thompson Vision - Omaha /ID# 271599
Omaha, Nebraska, 68137, United States
Oklahoma Eye Surgeons /ID# 269174
Oklahoma City, Oklahoma, 73112, United States
Ophthalmic Partners of PA /ID# 276059
Bala-Cynwyd, Pennsylvania, 19004, United States
Wills Eye Hospital Glaucoma Dept /ID# 268569
Philadelphia, Pennsylvania, 19107, United States
Glaucoma Associates Of Texas /ID# 268745
Dallas, Texas, 75231, United States
UT Southwestern Medical Center /ID# 268571
Dallas, Texas, 75390, United States
El Paso Eye Surgeons /ID# 268356
El Paso, Texas, 79902, United States
Berkeley Eye Center - Houston Greenway Plaza /ID# 277078
Houston, Texas, 77027, United States
University of Virginia /ID# 277487
Charlottesville, Virginia, 22908, United States
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119
Roanoke, Virginia, 24016, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2025
First Posted
February 12, 2025
Study Start
February 11, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03
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.