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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
NCT06822738 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE XEN63 Glaucoma Treatment System
Study Locations (20)
Texas
- Glaucoma Associates Of Texas /ID# 268745 — Dallas
- UT Southwestern Medical Center /ID# 268571 — Dallas
- El Paso Eye Surgeons /ID# 268356 — El Paso
- Berkeley Eye Center - Houston Greenway Plaza /ID# 277078 — Houston
California
- LA Glaucoma Group /ID# 268444 — Culver City
- North Bay Eye Associates /ID# 277071 — Petaluma
Colorado
- University Of Colorado - Anschutz Medical Campus /ID# 269947 — Aurora
- Colorado Eye Institute /ID# 277072 — Colorado Springs
Florida
- Brandon Eye Associates - Brandon /ID# 277074 — Brandon
- New Vision Eye Center /ID# 269955 — Vero Beach
Pennsylvania
- Ophthalmic Partners of PA /ID# 276059 — Bala-Cynwyd
- Wills Eye Hospital Glaucoma Dept /ID# 268569 — Philadelphia
Arizona
- Arizona Advanced Eye Research Institute /ID# 268363 — Glendale
Georgia
- Coastal Research Associates - Roswell /ID# 268458 — Roswell
Illinois
- Illinois Eye Center - Peoria Location /ID# 277127 — Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-02-11 |
| Est. Completion | 2028-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06822738
The ClinicalTrials.gov registry entry for NCT06822738 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Open Angle Glaucoma appearing as the primary indexed condition, and to 1 intervention — of which XEN63 Glaucoma Treatment System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06822738 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06822738 about?
NCT06822738 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06822738?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2025-02-11. Estimated completion is 2028-11.
What conditions does trial NCT06822738 study?
This clinical trial studies the following conditions: Primary Open Angle Glaucoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06822738?
The interventions under investigation include: XEN63 Glaucoma Treatment System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06822738?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06822738 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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