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NCT06822738 · ClinicalTrials.gov registry record · Phase 3
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 of Primary Open Angle Glaucoma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT06822738 is a Phase 3 study of Primary Open Angle Glaucoma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 130 participants, below the 288-participant average among 19 other Primary Open Angle Glaucoma trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT06822738, a Phase 3 study of Primary Open Angle Glaucoma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 19 other Primary Open Angle Glaucoma trials with a reported enrollment target (55% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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.
NCT06822738 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Texas, California, Colorado.
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.
What interventions are being tested in trial NCT06822738?
The interventions under investigation include: XEN63 Glaucoma Treatment System (DEVICE).
Who is sponsoring clinical trial NCT06822738?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
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