Trial studying safety and effects for Primary Open Angle Glaucoma
Official title 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
ClinicalTrials.gov ID: NCT06822738
What this study is testing
- What it's testing
- The study looks at how safe and effective the XEN63 gel stent is when placed inside or outside the eye, and how it affects eye pressure over time.
- Who it's for
- Adults 45 years or older who have primary open angle glaucoma and whose eye drops or other surgeries have not worked.
- What's involved
- Participants will have the XEN63 stent implanted on Day 1 and will visit the clinic for regular eye exams and safety checks.
- Time commitment
- The study lasts 12 months, with scheduled visits at the hospital or clinic during that period.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join 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...
- Uncontrolled by medical therapy (to meet out-of-US [OUS] requirements) with participants who only have glaucoma uncontrolled by medical therapy...
You likely can't join 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...
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the SE.
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, Arizona, United States
- Culver City, California, United States
- Petaluma, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Brandon, Florida, United States
- Jacksonville, Florida, United States
- Roswell, Georgia, United States
- New Orleans, Louisiana, United States
- Reading, Massachusetts, United States
- Fraser, Michigan, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Bala-Cynwyd, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, Arizona, United States; Culver City, California, United States; Petaluma, California, United States; Aurora, Colorado, United States; Colorado Springs, Colorado, United States; Brandon, Florida, United States and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.