Refractory GlaucomaNCT04303897
Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma
An observational study of Refractory Glaucoma, run by Allergan at 1 site in China.
Trial summary
Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Glaucoma
- What is being tested?
- XEN Glaucoma Stent
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2019to 3 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients are being implanted with the approved XEN product via the specific urgent medical needs for named patient use regulatory pathway in Hainan. The XEN Glaucoma Treatment System (XEN) is comprised of the XEN45 Gel Stent and XEN® Injector.
Who may be able to join
- Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy
Who cannot join
- Angle closure glaucoma where angle has not been surgically opened
- Previous glaucoma shunt/valve in the target quadrant
- Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
- Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
- Active iris neovascularization or neovascularization of the iris within six months of the surgical date
- Anterior chamber intraocular lens
- Presence of intraocular silicone oil
- Vitreous present in the anterior chamber
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma
Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.
- Conditions
- Refractory Glaucoma
- Being tested
- XEN Glaucoma Stent
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN Glaucoma StentDevice
Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan
| Study group | Role | What they receive |
|---|---|---|
| XEN Glaucoma Stent | Not described Receives: Device: XEN Glaucoma Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline
Measured: Baseline to Month 12
Secondary outcomes (1)
Mean decrease in IOP
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 posted11 Mar 2020
- Study start19 Dec 2019
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GlaucomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303897
- Sponsor's protocol ID
- 1924-801-007
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT04303897
- Acronym / sponsor ID
- 1924-801-007
- Conditions
- Refractory Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 11 Mar 2020 (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.
Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XEN Glaucoma Stent | – | Device: XEN Glaucoma Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are being implanted with the approved XEN product via the specific urgent medical needs for named patient use regulatory pathway in Hainan. The XEN Glaucoma Treatment System (XEN) is comprised of the XEN45 Gel Stent and XEN® Injector.
Key inclusion criteria (1 listed)
- Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy
Key exclusion criteria (8 listed)
- Angle closure glaucoma where angle has not been surgically opened
- Previous glaucoma shunt/valve in the target quadrant
- Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
- Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
- Active iris neovascularization or neovascularization of the iris within six months of the surgical date
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 |
|---|---|---|
| XEN Glaucoma StentData are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan | Device | XEN Glaucoma Stent |
Primary outcome
Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline
Time frame: Baseline to Month 12
1 secondary outcome
Mean decrease in IOP
Time frame: Baseline to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
ALLERGAN INC. study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Glaucoma, run by Allergan at 1 site 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline (time frame: Baseline to Month 12). 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 12 Apr 2024.