GlaucomaNCT04454138

Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement

An observational study of Glaucoma, run by Prism Eye Institute at 1 site in Canada.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 90 years
Conditions the study is for: Glaucoma
What is being tested?: XEN-45 gelatin microstent
Type of treatment: Medical device
How many people: 142 participants
Where: 1 siteCanada
Study dates: 25 Jun 2019to 20 Apr 2020
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 30 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

Who may be able to join

Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

Who cannot join

Other forms of glaucoma
Prior incisional glaucoma surgery
CPC
Prior corneal graft (PKP, DALK, DSAEK, DMEK).

Trial locations and contacts

1 site in 1 country.

Canada1 site

Prism Eye Institute
Oakville, Ontario, L6H 0J8

Other trials in Canada

About this study

The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery), the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a surgery known as supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

Read the detailed description

The Xen-45 gelatin microstent (Allergan, Dublin, Ireland) is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Creation of a filtering bleb through the gel stent and under the conjunctiva lowers intraocular pressure (IOP) by bypassing the natural outflow pathway of aqueous. A recent retrospective cohort study showed comparable safety and risk of failure to trabeculectomy. Amongst the main advantages of this device is the ability to create a bleb without dissecting and disrupting tissue, thus decreasing the amount of wound healing and potentially limiting bleb failure. However, despite demonstrating similar efficacy and safety to trabeculectomy,2 the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. Although antimetabolites, such as mitomycin C, have decreased reactionary wound healing that can result following surgery, fibrosis may still occur, especially when the components of the Xen-45 gelatin microstent are in close proximity to the fibroblastic structures of tenon's fascia.Tenon's capsule resembles a sponge-like layer with multiple adhesions to the overlying conjunctiva and underlying episclera. Implantation of the XEN within this space creates a higher risk of obstruction and subsequent failure. To ensure the lowest potential for occlusion, bleb scarring, and failure, one must ensure careful placement of the device in the subconjunctival space, avoiding intra-tenon's placement. Placement in the supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

Conditions: Glaucoma
Being tested: XEN-45 gelatin microstent
Medical subject headings: Glaucoma

What participants receive

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

XEN-45 gelatin microstentDevice
Placement either in the subconjunctival space or supratenon's area

Study groups in NCT04454138
Study group	Role	What they receive
Targeted supratenon's placement of XEN 45		Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Receives: Device: XEN-45 gelatin microstent
Non-targeted placement of XEN 45		Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. Receives: Device: XEN-45 gelatin microstent

What is being measured

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

Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications
Measured: Post op year 1
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications
Measured: Post op Year 1
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications
Measured: Post op year 1
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication
Measured: Post op Year 1
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications
Measured: Post op Year 1
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications
Measured: Post op year 1

Secondary outcomes (2)

Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
Presence or absence of the following complications:
1. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia. ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis
Measured: Post op year 1
Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.
Measured: Post op year 1

Timeline

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

25 Jun 201920 Apr 2020

First posted1 Jul 2020
Study start25 Jun 2019
Primary completion20 Apr 2020
Study completion20 Apr 2020

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 (4)Papers the sponsor has linked to this study.
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: Cohort
Time perspective: Retrospective
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04454138
Sponsor's protocol ID: 955
Status last verified: Aug 2020
First submitted: 23 Jun 2020
Last updated: 14 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.
PubMed 28237137
Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7.
PubMed 28601250
Fea AM, Spinetta R, Cannizzo PML, Consolandi G, Lavia C, Aragno V, Germinetti F, Rolle T. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent. J Ophthalmol. 2017;2017:9364910. doi: 10.1155/2017/9364910. Epub 2017 Jun 20.
PubMed 28751986
Sng CC, Wang J, Hau S, Htoon HM, Barton K. XEN-45 collagen implant for the treatment of uveitic glaucoma. Clin Exp Ophthalmol. 2018 May;46(4):339-345. doi: 10.1111/ceo.13087. Epub 2017 Nov 29.
PubMed 29053204

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

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
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
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma

All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement
ClinicalTrials.gov ID: NCT04454138
Acronym / sponsor ID: 955
Conditions: Glaucoma
Study type: Observational
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Prism Eye InstituteUniversity, hospital or other
Collaborators: Allergan
Study start: 25 Jun 2019 (actual)
Primary completion: 20 Apr 2020 (actual)
Study completion: 20 Apr 2020 (actual)
First posted: 1 Jul 2020 (actual)
Results: Posted 5 Aug 2020

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Targeted supratenon's placement of XEN 45	–	Device: XEN-45 gelatin microstentPlacement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
Non-targeted placement of XEN 45	–	Device: XEN-45 gelatin microstentImplantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.

Who may qualify

Ages: 30 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

Key inclusion criteria (1 listed)

Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

Key exclusion criteria (4 listed)

Other forms of glaucoma
Prior incisional glaucoma surgery
CPC
Prior corneal graft (PKP, DALK, DSAEK, DMEK).

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-45 gelatin microstentPlacement either in the subconjunctival space or supratenon's area	Device	Non-targeted placement of XEN 45, Targeted supratenon's placement of XEN 45

Primary outcome

Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.
Time frame: Post op year 1
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.
Time frame: Post op Year 1
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.
Time frame: Post op year 1
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.
Time frame: Post op Year 1
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.
Time frame: Post op Year 1
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.
Time frame: Post op year 1
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications

2 secondary outcomes

Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
Time frame: Post op year 1
Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
Time frame: Post op year 1

Results and safety

Results posted to the registry on 5 Aug 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
Non-targeted Placement of XEN 45	65	65
Targeted Supratenon's Placement of XEN 45	77	77

Primary outcome: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.

Time frame: Post op year 1. Count of participants. Unit: Participants

Measure	Non-targeted Placement of XEN 45 n = 65	Targeted Supratenon's Placement of XEN 45 n = 77
Value	20	15

Population analysed: Per protocol population

Primary outcome: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.

Time frame: Post op Year 1. Count of participants. Unit: Participants

Measure	Non-targeted Placement of XEN 45 n = 65	Targeted Supratenon's Placement of XEN 45 n = 77
Value	33	22

Population analysed: Per protocol population

Primary outcome: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.

Time frame: Post op year 1. Count of participants. Unit: Participants

Measure	Non-targeted Placement of XEN 45 n = 65	Targeted Supratenon's Placement of XEN 45 n = 77
Value	28	18

Population analysed: Per protocol polulation

Primary outcome: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.

Time frame: Post op Year 1. Count of participants. Unit: Participants

Measure	Non-targeted Placement of XEN 45 n = 65	Targeted Supratenon's Placement of XEN 45 n = 77
Value	41	26

Population analysed: per protocol population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-targeted Placement of XEN 45	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Targeted Supratenon's Placement of XEN 45	0 of 77 (0%)	0 of 77 (0%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28237137Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.
Background: PubMed 28601250Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7.
Background: PubMed 28751986Fea AM, Spinetta R, Cannizzo PML, Consolandi G, Lavia C, Aragno V, Germinetti F, Rolle T. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent. J Ophthalmol. 2017;2017:9364910. doi: 10.1155/2017/9364910. Epub 2017 Jun 20.
Background: PubMed 29053204Sng CC, Wang J, Hau S, Htoon HM, Barton K. XEN-45 collagen implant for the treatment of uveitic glaucoma. Clin Exp Ophthalmol. 2018 May;46(4):339-345. doi: 10.1111/ceo.13087. Epub 2017 Nov 29.
Individual participant dataSharing planned: No

Related trials for Glaucoma

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
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
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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.

Iqbal Ike Ahmed, MD principal investigator

Prism Eye Institute

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 Prism Eye Institute at 1 site in Canada.

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 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 14 Aug 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 Canada. 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 5 Aug 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?

Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement. (time frame: Post op year 1). The study lists 6 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 NCT04454138, which also lists 4 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 14 Aug 2020.