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
Open-angle Glaucoma, OAG
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open-angle glaucoma, OAG, XEN45, Intraocular pressure, IOP
Eligibility 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. Medicated 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. 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).
Sites / Locations
- Peking University Third Hospital /ID# 243994
- Xiangya Hospital Central South University /ID# 244599
- Jiangsu Province Hospital /ID# 244002
- West China Hospital, Sichuan University /ID# 243999
- The second Affiliated hospital of Zhejiang University school of Medicine /ID# 243996
- Beijing Tongren Hospital, CMU /ID# 244055
- The First Affiliated Hospital of Fujian Medical University /ID# 244004
- Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
- Qingdao Eye Hospital of Shandong First Medical University /ID# 243992
- Tianjin Eye Hospital /ID# 243997
- Eye Hospital, WMU Zhejiang Eye Hospital /ID# 243993
- Xiamen Eye Center of Xiamen University /ID# 244000
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
XEN45
Trabeculectomy
Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months.
Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months.