GlaucomaPhase 3NCT03362931

Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma

A Phase 3 study testing XEN45 in people with Glaucoma and Angle-Closure, run by Allergan at 16 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Angle-Closure
What is being tested?: XEN45
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 16 sitesin 6 countries
Study dates: 19 Jul 2018to 18 Mar 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion Criteria: - Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation - Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty o previous laser or incisional intraocular surgery that might interfere with the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in the study eye - Active or history of chronic uveitis in the study eye - Unable to discontinue contact lens wear in the study eye during the study

Who cannot join

None listed.

Trial locations and contacts

16 sites in 6 countries.

Country

City, postcode or hospital

16 sites in 6 countries

United Kingdom5 sites

East Suffolk and North Essex NHS Foundation Trust /ID# 232804
Colchester, CO4 5JL
Queen Victoria Hospital /ID# 232812
East Grinstead, West Sussex, RH19 3DZ
NHS Lothian /ID# 233052
Edinburgh, EH3 9HE
Royal Surrey County Hospital /ID# 233028
Guildford, England, GU2 7XX
Manchester University NHS Foundation Trust /ID# 232808
Manchester, Lancashire, M13 9WL

Other trials in United Kingdom

Australia3 sites

Melbourne Eye Specialists /ID# 232767
Fitzroy, Victoria, VIC3065
Marsden Eye Specialists Parramatta /ID# 232761
Parramatta, New South Wales, 2150
Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
Vermont South, Victoria, 3133

Other trials in Australia

Canada3 sites

Institut de loeil des Laurentides /ID# 232780
Boisbriand, Quebec, J7H 0E8
Prism Eye Institute /ID# 232917
Mississauga, L5L 1W8
Ophthalmology Clinic Bellevue /ID# 232782
Montreal, Quebec, H1V 1G5

Other trials in Canada

Singapore2 sites

Nuh Medical Centre /ID# 232905
Singapore, 119082
Tan Tock Seng Hospital /ID# 233014
Singapore, 308433

Other trials in Singapore

Taiwan2 sites

Buddhist Tzu Chi General Hospital /ID# 232664
Hualien City, Hualien, 97002
Taipei Veterans General Hospital /ID# 232948
Taipei City, Taipei, 11217

Other trials in Taiwan

South Korea1 site

Seoul National University Hospital /ID# 233099
Seoul, 03080

Other trials in South Korea

About this study

Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma

This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.

Conditions: Glaucoma, Angle-Closure
Being tested: XEN45
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XEN45Device
XEN45 unilaterally implanted in the study eye

Study groups in NCT03362931
Study group	Role	What they receive
XEN45 Glaucoma Treatment System (hereafter referred to as XEN)	Experimental	XEN45 unilaterally implanted in the study eye Receives: Device: XEN45

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12
IOP will be measured using a Goldmann applanation tonometer
Measured: Month 12

Secondary outcomes (1)

Change From Baseline the Number of Concomitant IOP-lowering Medications
The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 201818 Mar 2022

First posted5 Dec 2017
Study start19 Jul 2018
Primary completion18 Mar 2022
Study completion18 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03362931
Sponsor's protocol ID: 1924-701-007
Status last verified: Apr 2023
First submitted: 30 Nov 2017
Last updated: 17 May 2023
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
ClinicalTrials.gov ID: NCT03362931
Acronym / sponsor ID: 1924-701-007
Conditions: Glaucoma, Angle-Closure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 19 Jul 2018 (actual)
Primary completion: 18 Mar 2022 (actual)
Study completion: 18 Mar 2022 (actual)
First posted: 5 Dec 2017 (actual)
Results: Posted 17 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
XEN45 Glaucoma Treatment System (hereafter referred to as XEN)	Experimental	Device: XEN45XEN45 unilaterally implanted in the study eye

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion Criteria: - Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation - Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty o previous laser or incisional intraocular surgery that might interfere with the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in the study eye - Active or history of chronic uveitis in the study eye - Unable to discontinue contact lens wear in the study eye during the study

Key exclusion criteria (0 listed)

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
XEN45XEN45 unilaterally implanted in the study eye	Device	XEN45 Glaucoma Treatment System (hereafter referred to as XEN)

Primary outcome

Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12
Time frame: Month 12
IOP will be measured using a Goldmann applanation tonometer

1 secondary outcome

Change From Baseline the Number of Concomitant IOP-lowering Medications
Time frame: Month 12

Results and safety

Results posted to the registry on 17 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)	62	59

Primary outcome: Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12

Time frame: Month 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) n = 56
Value	80.5 (68.4 to 88.8)

Population analysed: Implanted population, defined as all subjects implanted with XEN45, with data at visit. (Missing data and data after the 1st non-study surgical procedures for IOP control or device explant are not counted or imputed.)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up tp 12 months after the initiation of XEN45 Implant related procedures. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)	12 of 62 (19.4%)	44 of 62 (71%)	2 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Glaucoma

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Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
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Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
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Retinitis Pigmentosa (RP), Rod Cone Dystrophy
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A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

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

16 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XEN45 in people with Glaucoma and Angle-Closure, run by Allergan at 16 sites in 6 countries.

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 0 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom, Australia, Canada, Singapore, Taiwan and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12 (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03362931.

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 17 May 2023.