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A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China

StatusActive, Not Recruiting
PhasePhase 4
SponsorAbbVie
Started2024-01-09
View on ClinicalTrials.gov ↗
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. The purpose of this study is to assess adverse events (AEs) and changes in disease activity in participants with open-angle glaucoma (OAG) receiving the XEN45 Glaucoma Treatment System (XEN45). XEN45 is an approved device for the treatment of OAG in participants in China who have not achieved satisfactory effectiveness with or are not suitable for intraocular pressure (IOP)-lowering medication, laser surgery, or are not tolerant of traditional filtration surgery. Adult participants with a diagnosis of OAG will be randomized to receive either XEN 45 or trabeculectomy. Around 130 participants will be enrolled in the study at approximately 15 sites in China. Participants will receive XEN45 implanted using the ab interno approach or trabeculectomy on Day 1 and will be followed for 60 months An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Amendment record

Amended 19 times since 2023-04-18; most recent filed 2026-04-23. 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 2026-08-29.

2026-04-23
Amendment RecruitingActive, Not Recruiting Study Status, Study Design, Contacts/Locations v19
2025-11-17
Amendment Study Status, Contacts/Locations v18
2025-11-14
Amendment Study Status, IPDSharing v17
2025-09-01
Amendment Study Status, Contacts/Locations v16
2025-01-22
Amendment Study Status, Contacts/Locations v15
2025-01-15
Amendment Study Status, Contacts/Locations v14
2025-01-02
Amendment Study Status, Outcome Measures, Eligibility, Contacts/Locations v13
2024-07-18
Amendment Study Status, Contacts/Locations, IPDSharing v12
2024-03-28
Amendment Study Status, Contacts/Locations v11
2024-03-27
Amendment Study Status, Contacts/Locations v10
2024-03-26
Amendment Study Status, Contacts/Locations v9
2024-03-25
Amendment Study Status, Contacts/Locations v8
2024-03-18
Amendment Study Status, Contacts/Locations v7
2024-03-15
Amendment Study Status v6
2024-03-01
Amendment Study Status, Contacts/Locations v5
2024-02-23
Amendment Study Status, Contacts/Locations v4
2024-01-29
Amendment Study Status, Contacts/Locations v3
2024-01-09
Amendment Study Status v2
2023-12-26
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v1
2023-04-18
Original filing
Trial Details
NCT Number NCT05821855
Lead Sponsor AbbVie
Conditions Open-angle Glaucoma, OAG
Enrollment 120 participants
Start Date 2024-01-09
Primary Completion 2030-07 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-28