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NCT05411198 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 74
- Enrollment target
NCT05411198 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 74 participants.
The verdict
NCT05411198, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 74 participants
- Enrollment target
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 externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States. All participants will receive XEN45 implanted using 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.
Interventions
- DEVICE XEN45 (Glaucoma Gel Stent)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2026-02-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05411198
The ClinicalTrials.gov registry entry for NCT05411198 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which XEN45 (Glaucoma Gel Stent) is the first listed.
NCT05411198 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05411198 about?
NCT05411198 is a clinical study titled "Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle 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 externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for...
What is the current status of trial NCT05411198?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2022-07-22. Estimated completion is 2026-02-04.
What interventions are being tested in trial NCT05411198?
The interventions under investigation include: XEN45 (Glaucoma Gel Stent) (DEVICE).
Who is sponsoring clinical trial NCT05411198?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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