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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Advanced Eye Research Institute /ID# 268363 — Glendale, Arizona
Age range: 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (28 Sites)
Showing the first 25 of 28 sites.
- Arizona Advanced Eye Research Institute /ID# 268363 — Glendale, Arizona
- LA Glaucoma Group /ID# 268444 — Culver City, California
- North Bay Eye Associates /ID# 277071 — Petaluma, California
- University Of Colorado - Anschutz Medical Campus /ID# 269947 — Aurora, Colorado
- Colorado Eye Institute /ID# 277072 — Colorado Springs, Colorado
- Eye Center of Northern Colorado /ID# 281798 — Fort Collins, Colorado
- Brandon Eye Associates - Brandon /ID# 277074 — Brandon, Florida
- East Coast Institute for Research /ID# 280411 — Jacksonville, Florida
- New Vision Eye Center /ID# 269955 — Vero Beach, Florida
- Coastal Research Associates - Roswell /ID# 268458 — Roswell, Georgia
- Illinois Eye Center - Peoria Location /ID# 277127 — Peoria, Illinois
- Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451 — Overland Park, Kansas
- Tulane Center for Clinical Research /ID# 277486 — New Orleans, Louisiana
- Fraser Eye Care Center /ID# 281837 — Fraser, Michigan
- Minnesota Eye Consultants - Minneapolis /ID# 272445 — Minneapolis, Minnesota
- Vance Thompson Vision - Omaha /ID# 271599 — Omaha, Nebraska
- Cincinnati Eye Institute /ID# 279773 — Cincinnati, Ohio
- Cleveland Clinic - Cleveland /ID# 277070 — Cleveland, Ohio
- Oklahoma Eye Surgeons /ID# 269174 — Oklahoma City, Oklahoma
- Ophthalmic Partners of PA /ID# 276059 — Bala-Cynwyd, Pennsylvania
- Wills Eye Hospital /ID# 268569 — Philadelphia, Pennsylvania
- Glaucoma Associates Of Texas /ID# 268745 — Dallas, Texas
- University of Texas - Southwestern Medical Center /ID# 268571 — Dallas, Texas
- El Paso Eye Surgeons /ID# 268356 — El Paso, Texas
- Berkeley Eye Center - Houston Greenway Plaza /ID# 277078 — Houston, Texas
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery) — Las Vegas, Nevada
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Explore by condition: All Primary Open Angle Glaucoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.