Primary Open Angle GlaucomaPhase 4NCT02006693

Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

A Phase 4 study testing XEN® Gel Stent and Cataract Surgery in people with Primary Open Angle Glaucoma, run by AqueSys, Inc. at 21 sites in 9 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open Angle Glaucoma
What is being tested?: XEN® Gel Stent and Cataract Surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 21 sitesin 9 countries
Study dates: 5 Dec 2013to 26 Jan 2017
Phase: Phase 4
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

Diagnosis of primary open angle glaucoma
Participants are taking at least one and no more than four topical IOP-lowering medications.

Who cannot join

Angle Closure Glaucoma
Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

Trial locations and contacts

21 sites in 9 countries.

Country

City, postcode or hospital

21 sites in 9 countries

United Kingdom5 sites

Birmingham Midland Eye Theaters
Birmingham, West Midlands, B18 7QH
Moorfields Eye Hospital
London, EC1V2PD
St. Thomas Hospital
London, SE17EH
Maidstone Hospital Eye, Ear and Mouth Unit
Maidstone, Kent, ME16 9QQ
Pinderfields Hospital
Wakefield, WF14DG

Other trials in United Kingdom

Austria3 sites

University of Graz
Graz, 8036
University Augenklinik Salzburg
Salzburg, 5020
Vienna University
Vienna, 1090

Other trials in Austria

Germany3 sites

University Eye Clinic Bochum-Langendreer
Bochum, 44892
Klinik für Augenheilkunde
Frankfurt, D-60590
Klinik fur Augenheilkunde
Neubrandenburg, 17036

Other trials in Germany

Italy3 sites

University of Pisa
Pisa, 56124
Clinica Oculistica, Universita' di Torino
Torino, 10100
Integrated University Hospital of Verona
Verona, 37126

Other trials in Italy

Spain3 sites

Hospital Universitario La Paz
Madrid, 28046
Hospital Principe de Asturias
Madrid
Hospital Meixeiro Servicio de Ofthalmologia
Vigo, Pontevedra

Other trials in Spain

Belgium1 site

University Hospitals Leuven
Leuven, B-3000

Other trials in Belgium

Poland1 site

Ophthalmology Department of the Military Health Service Institute
Warsaw, 04-141

Other trials in Poland

Switzerland1 site

University of Geneva
Geneva, 1211

Other trials in Switzerland

Venezuela1 site

Unidad Oftalmologica de Caracas
Caracas

Other trials in Venezuela

About this study

Official title: Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.

Conditions: Primary Open Angle Glaucoma
Being tested: XEN® Gel Stent, Cataract Surgery
Keywords: XEN, Primary Open Angle Glaucoma, Filtration Device, Ab interno
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.

XEN® Gel StentDevice
Also called XEN Glaucoma Implant, XEN Gel Stent, XEN45 Implant
The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
Cataract SurgeryProcedure or surgery
Participants diagnosed with a cataract elected to have cataract surgery.

Study groups in NCT02006693
Study group	Role	What they receive
XEN® Gel Stent	Other	The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. Receives: Device: XEN® Gel Stent
XEN® Gel Stent with Cataract Surgery	Other	The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. Receives: Procedure: Cataract Surgery

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) in the Study Eye to Month 12
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Measured: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Measured: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Mean Change From Baseline in IOP in the Study Eyes to Month 24
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Measured: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Measured: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)

Timeline

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

5 Dec 201326 Jan 2017

First posted10 Dec 2013 (estimated)
Study start5 Dec 2013
Primary completion9 Feb 2016
Study completion26 Jan 2017

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Primary Open Angle 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02006693
Sponsor's protocol ID: MS-001
Status last verified: Jan 2019
First submitted: 2 Dec 2013
Last updated: 22 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13.
PubMed 30758653
Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.
PubMed 29267575

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 Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
ClinicalTrials.gov ID: NCT02006693
Acronym / sponsor ID: MS-001
Conditions: Primary Open Angle Glaucoma
Keywords: XEN, Primary Open Angle Glaucoma, Filtration Device, Ab interno
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: AqueSys, Inc.Industry (pharma, biotech, devices)
Study start: 5 Dec 2013 (actual)
Primary completion: 9 Feb 2016 (actual)
Study completion: 26 Jan 2017 (actual)
First posted: 10 Dec 2013 (estimated)
Results: Posted 22 Apr 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
XEN® Gel Stent	Other	Device: XEN® Gel StentThe XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
XEN® Gel Stent with Cataract Surgery	Other	Procedure: Cataract SurgeryThe XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.

Who may qualify

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

Key inclusion criteria (2 listed)

Diagnosis of primary open angle glaucoma
Participants are taking at least one and no more than four topical IOP-lowering medications.

Key exclusion criteria (4 listed)

Angle Closure Glaucoma
Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

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® Gel StentAlso: XEN Glaucoma Implant, XEN Gel Stent, XEN45 ImplantThe XEN® Gel Stent (XEN45 implant) was placed in the study eye.	Device	XEN® Gel Stent
Cataract SurgeryParticipants diagnosed with a cataract elected to have cataract surgery.	Procedure or surgery	XEN® Gel Stent with Cataract Surgery

Primary outcome

Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Mean Change From Baseline in IOP in the Study Eyes to Month 24
Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.

Results and safety

Results posted to the registry on 22 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
XEN® Gel Stent	112	84
XEN® Gel Stent With Cataract Surgery	87	74

Primary outcome: Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12

Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative). Mean (Standard Deviation). Unit: mmHg

Measure	XEN® Gel Stent n = 106	XEN® Gel Stent With Cataract Surgery n = 79
Baseline (preoperation)	21.7 (3.76)	21.0 (3.39)
Change from Baseline to Month 12	-6.6 (5.64)	-6.4 (4.96)

Population analysed: mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.

Primary outcome: Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12

Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative). Mean (Standard Deviation). Unit: medications

Measure	XEN® Gel Stent n = 106	XEN® Gel Stent With Cataract Surgery n = 79
Baseline (preoperation)	2.7 (0.93)	2.5 (0.88)
Change from Baseline to Month 12	-1.8 (1.31)	-1.6 (1.17)

Primary outcome: Mean Change From Baseline in IOP in the Study Eyes to Month 24

Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative). Mean (Standard Deviation). Unit: mmHg

Measure	XEN® Gel Stent n = 106	XEN® Gel Stent With Cataract Surgery n = 79
Baseline (preoperation)	21.7 (3.76)	21.0 (3.39)
Change from Baseline to Month 24	-6.4 (5.18)	-5.9 (4.60)

Primary outcome: Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24

Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative). Mean (Standard Deviation). Unit: medications

Measure	XEN® Gel Stent n = 106	XEN® Gel Stent With Cataract Surgery n = 79
Baseline (preoperation)	2.7 (0.93)	2.5 (0.88)
Change from Baseline to Month 24	-1.5 (1.54)	-1.5 (1.22)

Adverse events

Time frame: Up to 26 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XEN® Gel Stent	12 of 120 (10%)	14 of 120 (11.7%)	2 of 112
XEN® Gel Stent With Cataract Surgery	6 of 98 (6.1%)	8 of 98 (8.2%)	2 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30758653Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13.
Derived from this study: PubMed 29267575Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.

Related trials for Primary Open Angle Glaucoma

RecruitingPhase 2
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Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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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.

Vanessa Vera, MD study director

Allergan

21 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing XEN® Gel Stent and Cataract Surgery in people with Primary Open Angle Glaucoma, run by AqueSys, Inc. at 21 sites in 9 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 2 inclusion and 4 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United Kingdom, Austria, Germany, Italy, Spain and 4 more countries. 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?

Yes. Results are posted in the registry (first posted 22 Apr 2019). 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) in the Study Eye to Month 12 (time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)). The study lists 4 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 NCT02006693, which also lists 2 linked publications.

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 22 Apr 2019.