Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06822738 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 3
SponsorAbbVie
Started2025-02-11
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 29 times since 2025-02-07; most recent filed 2026-08-13. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-13
Amendment Study Status, Contacts/Locations v29
2026-07-16
Amendment Study Status, Contacts/Locations v28
2026-06-24
Amendment Study Status, Contacts/Locations v27
2026-06-18
Amendment Study Status, Contacts/Locations v26
2026-06-16
Amendment Study Status, Contacts/Locations v25
2026-06-10
Amendment Study Status v24
2026-05-28
Amendment Study Status, Contacts/Locations v23
2026-05-11
Amendment Study Status, Contacts/Locations v22
2026-03-18
Amendment Study Status v21
2026-02-23
Amendment Study Status v20
2026-02-05
Amendment Study Status, Contacts/Locations v19
2026-01-15
Amendment Study Status, Contacts/Locations v18
2025-12-03
Amendment Study Status, Contacts/Locations v17
2025-11-27
Amendment Study Status, Contacts/Locations v16
2025-11-08
Amendment Study Status, Contacts/Locations v15
2025-10-31
Amendment Study Status, Contacts/Locations v14
2025-09-10
Amendment Study Status, Contacts/Locations v13
2025-08-06
Amendment Study Status, Contacts/Locations v12
2025-07-29
Amendment Study Status, Study Description, Study Design v11
2025-06-30
Amendment Study Status, Contacts/Locations v10
2025-06-20
Amendment Study Status v9
2025-05-21
Amendment Study Status, Contacts/Locations v8
2025-05-08
Amendment Study Status v7
2025-05-05
Amendment Study Status, Contacts/Locations v6
2025-04-29
Amendment Study Status, Contacts/Locations v5
2025-04-24
Amendment Study Status, Contacts/Locations v4
2025-04-21
Amendment Study Status v3
2025-03-18
Amendment Study Status, Study Description, Eligibility, Contacts/Locations v2
2025-02-11
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v1
2025-02-07
Original filing
Trial Details
NCT Number NCT06822738
Lead Sponsor AbbVie
Conditions Primary Open Angle Glaucoma
Enrollment 130 participants
Start Date 2025-02-11
Primary Completion 2028-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-14