Clinical trial NCT05821855: 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
Official title: A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Open-angle Glaucoma
OAG
Keywords: Open-angle glaucoma
OAG
XEN45
Intraocular pressure
IOP
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.
* 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.

Primary outcomes:
measure: Change from Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline to Month 12
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline to Month 60
Secondary outcomes:
measure: Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction
timeFrame: Baseline to Month 12
measure: Change from Baseline in IOP by Visit
timeFrame: Baseline to Month 12
measure: Change from Baseline in Number of Topical IOP-Lowering Medications
timeFrame: Baseline to Month 12
measure: Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications
timeFrame: Baseline to Month 12
measure: Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline With Any Topical IOP-Lowering Medications
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University people's hospital /ID# 265493
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 243994
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University /ID# 244004
state: Fujian
city: Xiamen
country: China
facility: Xiamen Eye Center of Xiamen University /ID# 244000
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital /ID# 244001
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST /ID# 243998
state: Hubei
city: Qingdao
country: China
facility: Qingdao Eye Hospital of Shandong First Medical University /ID# 243992
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 243999
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Eye Hospital /ID# 243997
state: Tianjin
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 243996
state: Zhejiang
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: