Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)

An observational study of Glaucoma, run by Allergan at 1 site in United States.

Completed

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

Trial summary

A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015. Read more about this study

Who is it for?: Any age
Conditions the study is for: Glaucoma
What is being tested?: XEN Group and Phacoemulsification
Type of treatment: Medical device, Surgery or procedure
How many people: 174 participants
Where: 1 siteUnited States
Study dates: 5 Apr 2019to 25 Oct 2019
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participant eyes that underwent XEN 45 Gel Stent implantation from 1 January 2014 until 1 October 2015.

Who may be able to join

Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Trials Registry Team
Irvine, California, 92622

Other trials in United States

About this study

Official title: XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)

Conditions: Glaucoma
Being tested: XEN Group, Phacoemulsification
Medical subject headings: Glaucoma

What participants receive

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

XEN GroupDevice
Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015.
PhacoemulsificationProcedure or surgery
Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015.

Study groups in NCT03868254
Study group	Role	What they receive
Implant		Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. Receives: Device: XEN Group
Implant + Phaco		Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. Receives: Procedure: Phacoemulsification

What is being measured

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

Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation
IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation

Secondary outcomes (7)

Change From Baseline in Mean IOP to 48 Months After Implantation
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation
IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Percentage of Eyes Achieving Qualified Success at Month 36
Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Percentage of Eyes Achieving Qualified Success at Month 48
Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Percentage of Eyes Achieving Complete Success at Month 36
Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Percentage of Eyes Achieving Complete Success at Month 48
Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Percentage of Eyes With Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a drug whether or not it is considered related to drug. AESI include: Glaucoma, defined as damage to optic nerve with progressive vision loss, Intraocular hypertension, defined as IOP without meeting criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation. Data of AESIs are presented based on eyes for this outcome measure.
Measured: Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months

Timeline

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

5 Apr 201925 Oct 2019

First posted11 Mar 2019
Study start5 Apr 2019
Primary completion25 Oct 2019
Study completion25 Oct 2019

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: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03868254
Sponsor's protocol ID: CMO-MA-EYE-0590
Status last verified: Oct 2020
First submitted: 7 Mar 2019
Last updated: 17 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

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 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
ClinicalTrials.gov ID: NCT03868254
Acronym / sponsor ID: CMO-MA-EYE-0590
Conditions: Glaucoma
Study type: Observational
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 5 Apr 2019 (actual)
Primary completion: 25 Oct 2019 (actual)
Study completion: 25 Oct 2019 (actual)
First posted: 11 Mar 2019 (actual)
Results: Posted 17 Nov 2020

Clinical summary

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

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Implant	–	Device: XEN GroupChart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.
Implant + Phaco	–	Procedure: PhacoemulsificationChart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participant eyes that underwent XEN 45 Gel Stent implantation from 1 January 2014 until 1 October 2015.

Key inclusion criteria (2 listed)

Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015

Key exclusion criteria (1 listed)

None

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 GroupChart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015.	Device	Implant
PhacoemulsificationChart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015.	Procedure or surgery	Implant + Phaco

Primary outcome

Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.

7 secondary outcomes

Change From Baseline in Mean IOP to 48 Months After Implantation
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
Percentage of Eyes Achieving Qualified Success at Month 36
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Percentage of Eyes Achieving Qualified Success at Month 48
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Percentage of Eyes Achieving Complete Success at Month 36
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
Percentage of Eyes Achieving Complete Success at Month 48
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
Percentage of Eyes With Adverse Events of Special Interest (AESIs)
Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months

Results and safety

Results posted to the registry on 17 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implant	98	98
Implant + Phaco	76	76

Primary outcome: Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation

Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation. Mean (Standard Deviation). Unit: mm Hg

Measure	Implant n = 90	Implant + Phaco n = 73
Baseline	21.03 (4.638)	20.21 (5.640)
Change from Baseline to Month 36	-6.42 (5.655)	-6.73 (7.620)

Implant: p <.0001, Paired t-test
Implant + Phaco: p <.0001, Paired t-test

Population analysed: Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint.

Primary outcome: Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation

Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation. Mean (Standard Deviation). Unit: medications

Measure	Implant n = 90	Implant + Phaco n = 73
Baseline	2.6 (0.98)	2.4 (1.02)
Change from Baseline to Month 36	-1.6 (1.49)	-1.2 (1.52)

Implant: p <.0001, Paired t-test
Implant + Phaco: p = 0.0001, Paired t-test

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implant	2 of 98 (2%)	0 of 98 (0%)	0 of 98
Implant + Phaco	0 of 76 (0%)	0 of 76 (0%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Mini Balaram, MD 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 Glaucoma, run by Allergan at 1 site in United States.

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 2 inclusion and 1 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 Nov 2020. 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 United States. 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?

Yes. Results are posted in the registry (first posted 17 Nov 2020). 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?

Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation (time frame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation). 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?

On the ClinicalTrials.gov record for NCT03868254.

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 Nov 2020.