Evaluating the XEN45 Glaucoma Treatment System for Open-Angle Glaucoma in Adults
A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China
This study is testing if the XEN45 Glaucoma Treatment System can safely help adults with open-angle glaucoma who haven't had success with other treatments, comparing it to a traditional surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 12 sites (Beijing, Beijing and 11 other locations) |
| Trial ID | NCT05821855 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of the XEN45 Glaucoma Treatment System in adults with open-angle glaucoma (OAG) who have not responded well to other treatments. Participants will be randomly assigned to receive either the XEN45 implant or undergo trabeculectomy, a traditional surgical procedure. The study will monitor adverse events and changes in disease activity over a period of 60 months across approximately 15 sites in China. The goal is to determine the long-term outcomes of the XEN45 system compared to standard surgical options.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with open-angle glaucoma who have not achieved satisfactory results with medications or are unsuitable for traditional surgical options.
Not a fit: Patients with active neovascular, uveitic, or angle-recession glaucoma, or those who have had prior surgeries affecting the study eye may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing intraocular pressure in patients with open-angle glaucoma.
How similar studies have performed: Other studies have shown promising results with similar glaucoma treatment devices, indicating potential for success with the XEN45 system.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit in the study eye. * 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.
Where this trial is running
Beijing, Beijing and 11 other locations
- Peking University people's hospital /ID# 265493 — Beijing, Beijing, China (Recruiting)
- Peking University Third Hospital /ID# 243994 — Beijing, Beijing, China (Recruiting)
- Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055 — Beijing, Beijing, China (Recruiting)
- The First Affiliated Hospital Of Fujian Medical University /ID# 244004 — Fuzhou, Fujian, China (Recruiting)
- Xiamen Eye Center of Xiamen University /ID# 244000 — Xiamen, Fujian, China (Recruiting)
- Shenzhen Eye Hospital /ID# 244001 — Shenzhen, Guangdong, China (Recruiting)
- Tongji Hospital Tongji Medical College of HUST /ID# 243998 — Wuhan, Hubei, China (Recruiting)
- Qingdao Eye Hospital of Shandong First Medical University /ID# 243992 — Qingdao, Shandong, China (Recruiting)
- West China Hospital, Sichuan University /ID# 243999 — Chengdu, Sichuan, China (Recruiting)
- Tianjin Eye Hospital /ID# 243997 — Tianjin, Tianjin, China (Recruiting)
- The second affiliated hospital of Zhejiang University school of medicine /ID# 243996 — Hangzhou, Zhejiang, China (Recruiting)
- Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843 — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.