Open-angle GlaucomaPhase 4NCT03904381

Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma

A Phase 4 study testing 5-fluorouracil, Transconjunctival needling and Transconjunctival revision in people with Open-angle Glaucoma, run by Wroclaw Medical University at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-angle Glaucoma
What is being tested?: 5-fluorouracil, Transconjunctival needling and Transconjunctival revision
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 sitePoland
Study dates: 1 Jan 2016to 1 Jan 2025
Phase: Phase 4
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

Who may be able to join

diagnosis of primary open angle glaucoma
trabecular meshwork visible in gonioscopy
medicated IOP of ≥ 15 mmHg and ≤ 35 mmHg
taking 1 to 5 IOP-lowering medications
area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)
signed inform consent

Who cannot join

angle closure glaucoma
secondary open angle glaucoma
previous glaucoma shunt/valve in the target quadrant
presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
active iris neovascularization or neovascularization of the iris within 6 months of the surgical date

Show all 13Show fewer

anterior chamber intraocular lens
presence of intraocular silicone oil
vitreous present in the anterior chamber
impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde)
history of dermatologic keloid formation
previous photorefractive keratectomy

Trial locations and contacts

1 site in 1 country.

Poland1 site

Department of Ophthalmology
Wroclaw, 54-622

Other trials in Poland

About this study

Official title: Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma Compared to Classic Glaucoma Surgeries (Trabeculectomy and Sclerectomy) as Well as Other Minilally Invasive Glaucoma Surgery (MIGS)

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.

Conditions: Open-angle Glaucoma
Being tested: 5-fluorouracil, Transconjunctival needling, Transconjunctival revision
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.

5-fluorouracilDrug
5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.
Transconjunctival needlingProcedure or surgery
Transconjunctival needling was administered according to predetermined criteria.
Transconjunctival revisionProcedure or surgery
Transconjunctival revision was administered according to predetermined criteria.

Study groups in NCT03904381
Study group	Role	What they receive
stand-alone procedure of XEN implantation in phakic eyes	Active comparator	Not described Receives: Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision
stand-alone procedure of XEN implantation in pseudophakic eyes	Active comparator	Not described Receives: Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision
XEN implantation combined with cataract extraction	Active comparator	Not described Receives: Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision

What is being measured

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

Unqualified success
Unqualified success of glaucoma treatment, defined as a postoperative IOP <18 mmHg and >20% reduction compared with the baseline value, achieved without use of any antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
Measured: 5 years

Secondary outcomes (3)

Qualified success score A
Qualified success of glaucoma treatment, defined as a postoperative IOP <21 mmHg and >20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
Measured: 5 years
Qualified success score B
Qualified success of glaucoma treatment, defined as a postoperative IOP < 18 mmHg and >20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
Measured: 5 years
Qualified success score C
Qualified success of glaucoma treatment, defined as a postoperative IOP ≤15 mmHg and >40% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
Measured: 5 years

Timeline

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

1 Jan 20161 Jan 2025

First posted5 Apr 2019
Study start1 Jan 2016
Primary completion1 Jan 2024 (estimated)
Study completion1 Jan 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 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: Health services research
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03904381
Sponsor's protocol ID: STM.C240.17.037
Status last verified: Mar 2022
First submitted: 3 Apr 2019
Last updated: 29 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Budenz DL, Rhee P, Feuer WJ, McSoley J, Johnson CA, Anderson DR. Comparison of glaucomatous visual field defects using standard full threshold and Swedish interactive threshold algorithms. Arch Ophthalmol. 2002 Sep;120(9):1136-41. doi: 10.1001/archopht.120.9.1136.
PubMed 12215086
Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059.
PubMed 19834563

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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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.
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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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RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
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All Open-angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma Compared to Classic Glaucoma Surgeries (Trabeculectomy and Sclerectomy) as Well as Other Minilally Invasive Glaucoma Surgery (MIGS)
ClinicalTrials.gov ID: NCT03904381
Acronym / sponsor ID: STM.C240.17.037
Conditions: Open-angle Glaucoma
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Wroclaw Medical UniversityUniversity, hospital or other
Collaborators: Wrocław University of Science and Technology
Study start: 1 Jan 2016 (actual)
Primary completion: 1 Jan 2024 (estimated)
Study completion: 1 Jan 2025 (estimated)
First posted: 5 Apr 2019 (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.

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
stand-alone procedure of XEN implantation in phakic eyes	Active comparator	Drug: 5-fluorouracil, Procedure: Transconjunctival needling, Procedure: Transconjunctival revision
stand-alone procedure of XEN implantation in pseudophakic eyes	Active comparator	Drug: 5-fluorouracil, Procedure: Transconjunctival needling, Procedure: Transconjunctival revision
XEN implantation combined with cataract extraction	Active comparator	Drug: 5-fluorouracil, Procedure: Transconjunctival needling, Procedure: Transconjunctival revision

Who may qualify

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

Key inclusion criteria (6 listed)

diagnosis of primary open angle glaucoma
trabecular meshwork visible in gonioscopy
medicated IOP of ≥ 15 mmHg and ≤ 35 mmHg
taking 1 to 5 IOP-lowering medications
area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)

Key exclusion criteria (13 listed)

angle closure glaucoma
secondary open angle glaucoma
previous glaucoma shunt/valve in the target quadrant
presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)

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
5-fluorouracil5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.	Drug	XEN implantation combined with cataract extraction, stand-alone procedure of XEN implantation in phakic eyes, stand-alone procedure of XEN implantation in pseudophakic eyes
Transconjunctival needlingTransconjunctival needling was administered according to predetermined criteria.	Procedure or surgery	XEN implantation combined with cataract extraction, stand-alone procedure of XEN implantation in phakic eyes, stand-alone procedure of XEN implantation in pseudophakic eyes
Transconjunctival revisionTransconjunctival revision was administered according to predetermined criteria.	Procedure or surgery	XEN implantation combined with cataract extraction, stand-alone procedure of XEN implantation in phakic eyes, stand-alone procedure of XEN implantation in pseudophakic eyes

Primary outcome

Unqualified success
Time frame: 5 years
Unqualified success of glaucoma treatment, defined as a postoperative IOP <18 mmHg and >20% reduction compared with the baseline value, achieved without use of any antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.

3 secondary outcomes

Qualified success score A
Time frame: 5 years
Qualified success score B
Time frame: 5 years
Qualified success score C
Time frame: 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
Background: PubMed 12215086Budenz DL, Rhee P, Feuer WJ, McSoley J, Johnson CA, Anderson DR. Comparison of glaucomatous visual field defects using standard full threshold and Swedish interactive threshold algorithms. Arch Ophthalmol. 2002 Sep;120(9):1136-41. doi: 10.1001/archopht.120.9.1136.
Background: PubMed 19834563Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059.
Individual participant dataSharing planned: No

Related trials for Open-angle Glaucoma

RecruitingPhase 2
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)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

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.

Marta Misiuk-Hojło, Professor study chair

Medical University of Wrocław

Ewa Wałek principal investigator

Medical University of Wrocław

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 5-fluorouracil, Transconjunctival needling and Transconjunctival revision in people with Open-angle Glaucoma, run by Wroclaw Medical University at 1 site in Poland.

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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. 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 Poland. 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?

Results are not available in the source record.

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?

Unqualified success (time frame: 5 years). 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 NCT03904381, 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 29 Mar 2022.