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

Study Identifier
1924-802-007
CT.gov Identifier
NCT05821855
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Glaucoma - Open Angle
    • Study Drug
    N/A
    Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and 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.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Peking University people s hospital /ID# 265493
    Beijing, Beijing Municipality, China, 100044
    Status
    Not applicable
    Location
    Peking University Third Hospital /ID# 243994
    Beijing, Beijing Municipality, China, 100191
    Status
    Not applicable
    Location
    Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055
    Beijing, Beijing Municipality, China, 100730
    Status
    Not applicable
    Location
    The First Affiliated Hospital Of Fujian Medical University /ID# 244004
    Fuzhou, Fujian, China, 350005
    Status
    Not applicable
    Location
    Xiamen Eye Center of Xiamen University /ID# 244000
    Xiamen, Fujian, China, 390000
    Status
    Not applicable
    Location
    The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493
    Guangzhou, Guangdong, China, 510260
    Status
    Not applicable
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