Open-angle GlaucomaPhase 4NCT05821855
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 Phase 4 study testing XEN45 Glaucoma Treatment System and Trabeculectomy in people with Open-angle Glaucoma and OAG, run by AbbVie at 13 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, OAG
- What is being tested?
- XEN45 Glaucoma Treatment System and Trabeculectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesChina
- Study dates
- 9 Jan 2024to Jul 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Peking University people s hospital /ID# 265493
Beijing, Beijing Municipality, 100044
Peking University Third Hospital /ID# 243994
Beijing, Beijing Municipality, 100191
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055
Beijing, Beijing Municipality, 100730
West China Hospital, Sichuan University /ID# 243999
Chengdu, Sichuan, 610041
The First Affiliated Hospital Of Fujian Medical University /ID# 244004
Fuzhou, Fujian, 350005
The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493
Guangzhou, Guangdong, 510260
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
Guangzhou, 510623
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996
Hangzhou, Zhejiang, 310009
Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992
Qingdao, Shandong, 266071
Shenzhen Eye Hospital /ID# 244001
Shenzhen, Guangdong, 518034
Tianjin Eye Hospital /ID# 243997
Tianjin, Tianjin Municipality, 300070
Tongji Hospital Tongji Medical College of HUST /ID# 243998
Wuhan, Hubei, 430030
Xiamen Eye Center of Xiamen University /ID# 244000
Xiamen, Fujian, 390000
About this study
Official title: A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China
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.
Read more
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.
- Conditions
- Open-angle Glaucoma, OAG
- Being tested
- XEN45 Glaucoma Treatment System, Trabeculectomy
- Keywords
- Open-angle glaucoma, OAG, XEN45, Intraocular pressure, IOP
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN45 Glaucoma Treatment SystemDevice
Ab interno implantation
TrabeculectomyProcedure or surgery
Surgical Intervention
| Study group | Role | What they receive |
|---|---|---|
| XEN45 | Experimental | Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months. Receives: Device: XEN45 Glaucoma Treatment System |
| Trabeculectomy | Active comparator | Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months. Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Measured: Baseline to Month 12
Number of Participants with Adverse Events (AEs)
An 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.
Measured: Baseline to Month 60
Secondary outcomes (5)
Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction
Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications without secondary surgical intervention (SSI) for uncontrolled IOP.
Measured: Baseline to Month 12
Change from Baseline in IOP by Visit
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Measured: Baseline to Month 12
Change from Baseline in Number of Topical IOP-Lowering Medications
A numerical count by class of drug of topical IOP lowering medications being taken.
Measured: Baseline to Month 12
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications
The complete treatment response is defined as the percentage of participants achieving IOP <=18 mm Hg and 20% or more reduction of IOP without topical IOP medications from baseline.
Measured: Baseline to Month 12
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline With Any Topical IOP-Lowering Medications
The qualified treatment response is defined as the percentage of participants achieving IOP <= 18 mm Hg and 20% mean IOP reduction from baseline with any topical IOP-lowering medications.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start9 Jan 2024
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821855
- Sponsor's protocol ID
- 1924-802-007
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China
- ClinicalTrials.gov ID
- NCT05821855
- Acronym / sponsor ID
- 1924-802-007
- Conditions
- Open-angle Glaucoma, OAG
- Keywords
- Open-angle glaucoma, OAG, XEN45, Intraocular pressure, IOP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XEN45 | Experimental | Device: XEN45 Glaucoma Treatment SystemParticipants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months. |
| Trabeculectomy | Active comparator | Procedure: TrabeculectomyParticipants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XEN45 Glaucoma Treatment SystemAb interno implantation | Device | XEN45 |
| TrabeculectomySurgical Intervention | Procedure or surgery | Trabeculectomy |
Primary outcome
Change from Baseline in Intraocular Pressure (IOP)
Time frame: Baseline to Month 12
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Number of Participants with Adverse Events (AEs)
Time frame: Baseline to Month 60
An 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.
5 secondary outcomes
Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction
Time frame: Baseline to Month 12
Change from Baseline in IOP by Visit
Time frame: Baseline to Month 12
Change from Baseline in Number of Topical IOP-Lowering Medications
Time frame: Baseline to Month 12
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications
Time frame: Baseline to Month 12
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline With Any Topical IOP-Lowering Medications
Time frame: Baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XEN45 Glaucoma Treatment System and Trabeculectomy in people with Open-angle Glaucoma and OAG, run by AbbVie at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Intraocular Pressure (IOP) (time frame: Baseline to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.