NCT05821855Active, not recruitingPhase 4
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
A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 23 Mar 2023
- Start date
- 9 Jan 2024
- Primary completion date
- Jul 2030
- Lead sponsor
- AbbVie
- Diseases
- Glaucoma
- NCT number
- NCT05821855
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 120
- From 9 Jan 2024 to the primary completion date, Jul 2030
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior XEN45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation \[UC3\], etc.) or prior major conjunctival surgery (i.e., scleral buckle) in the study eye.
Other illness
- Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit in the study eye.
Who the study is looking for
- Area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva.
- Visible trabecular meshwork with Shaffer angle grade =\> 3 in the study eye at the Screening Visit.
- IOP =\> 20 mm Hg and \<= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital /ID# 243994 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University people s hospital /ID# 265493 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital, Sichuan University /ID# 243999 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital Of Fujian Medical University /ID# 244004 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992 Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shenzhen Eye Hospital /ID# 244001 Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Tianjin Eye Hospital /ID# 243997 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongji Hospital Tongji Medical College of HUST /ID# 243998 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xiamen Eye Center of Xiamen University /ID# 244000 Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.