Glaucoma, Open-AngleNCT04750447
Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C
An observational study of Glaucoma, Open-Angle, run by Prism Eye Institute at 1 site in Canada.
Trial summary
The Xen gelatin microstent (Allergan, CA, USA) is a 6mm hydrophobic, bleb-forming microinvasive glaucoma surgery (MIGS).1 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- XEN 63
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2020to 9 Jun 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled to undergo Xen 63 implantation for open angle glaucoma with or without cataract surgery
Who may be able to join
- Patients aged 30-90 Primary open angle glaucoma on maximum tolerated medical therapy Going to receive XEN63 ab interno gelatin stent with or without MMC in study eye ± cataract surgery
Who cannot join
- Other forms of glaucoma
- Previous glaucoma shunt/valve in the target quadrant of study eye
- Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant of study eye
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis), active iris neovascularization or neovascularization of the iris within six months of the surgical date
- Presence of anterior chamber intraocular lens, 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.
- Prior CPC, corneal graft (PKP, DALK, DSAEK, DMEK)
- Other forms of combined surgery (cornea, retina) besides cataract surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Prism Eye Institute
Oakville, Ontario, L6H 0J8
Ronaldo Santiago, MD, (905) 456-3937 ext. 267, ike.research@prismeye.ca
About this study
The Xen gelatin microstent (Allergan, CA, USA) is a 6mm hydrophobic, bleb-forming microinvasive glaucoma surgery (MIGS).1 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. Currently three Xen models have been developed: 45, 63, and 140 um internal lumen diameters.2 XEN45 ab interno gelatin stent was the first to be approved for clinical use in Canada.3 A recent retrospective cohort study showed comparable safety and risk of failure to trabeculectomy.4 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. Recently, the XEN63 ab interno gelatin stent was approved by Health Canada for clinical use in Canada. Being a new device, to date, no study has examined the effect of XEN63 ab interno gelatin stent on anti-glaucoma drops burden and IOP. The aim of this study is to investigate the safety and efficacy of the XEN63 ab interno gelatin stent to provide insights for ophthalmologists who will want to add this technique to their practice.
Read the detailed description
- This is a prospective, single-arm, open-label clinical trial designed to demonstrate the safety and IOP-lowering effectiveness of XEN 63. Approximately 29 patients who are scheduled to undergo glaucoma surgery with XEN63 implantation will be enrolled and followed for up to 12 months postoperatively. Enrollees will follow the standard of care visits (pre-op, post-op day 1, post-op week 1 and post op month 1) where they will undergo a full eye exam (visual acuity, refraction, slit lamp exam and intraocular pressure measurement). In addition to the standard of care visit, enrollees will have 2 additional visits (post-op month 6 and post-op month 12) where they will undergo a full eye exam. Additional tests include a Visual Field assessment and Endothelial cell count on their pre-op visit, post-operative month visit 6 and post-op month 12 visit.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- XEN 63
- 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 63Device
The Xen gelatin microstent (Allergan, CA, USA) is a 6mm gelatin tube used in microinvasive glaucoma surgery (MIGS) to create a bleb. A bleb is a fluid filled blister located in the tissue covering the white portion of the eye (the conjunctiva) created after glaucoma surgery. The bleb allows the eye pressure (intraocular pressure - IOP) to be lowered by bypassing the natural pathways by which the fluid called aqueous leaves the eye and redirecting it towards the bleb to be absorbed by other pathways. Amongst the main advantages of this device is the ability to create a bleb without disrupting tissue unlike other methods of glaucoma surgery (e.g., trabeculectomy). This decreases the amount of wound healing and scarring, and potentially limiting bleb failure.
| Study group | Role | What they receive |
|---|---|---|
| Open Angle Glaucoma | Patients aged 30-90 Primary open angle glaucoma on maximum tolerated medical therapy Going to receive XEN63 ab interno gelatin stent with or without MMC in study eye ± cataract surgery Receives: Device: XEN 63 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Success
Intraocular Pressure: 6-17 mmHg and on no glaucoma medications at least 1 month after surgery with no reoperation using the Goldmann Applanation Tonometer..
Measured: 1 month post op to post op month 12
Absence of complications
Absence of the following complications as reported during slitlamp examination:
- Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, 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, blebitis/endophthalmitis
Measured: post op day 1 to post op month 12
Qualified Success
- 'Complete success' criteria except that Intraocular Pressure (IOP) can be above IOP thresholds, and then reduced to within the 'Complete criteria' by medications or laser in 3 visits or less as measured by Goldmann Applanation Tonometry.
Measured: post op month 1 to post op month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start9 Nov 2020
- Primary completion9 Jun 2023 (estimated)
- Study completion9 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Prism Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Iqbal Ahmed, Prism Eye Institute
- Investigators
- Iqbal Ahmed, MD, Principal investigator, Prism Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750447
- Sponsor's protocol ID
- 1035
- Status last verified
- Sep 2022
- First submitted
- 9 Feb 2021
- Last updated
- 28 Sep 2022
- Results posted
- 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 28237137Green W, Lind JT, Sheybani A. Review of the Xen Gel Stent and InnFocus MicroShunt. Curr Opin Ophthalmol. 2018 Mar;29(2):162-170. doi: 10.1097/ICU.0000000000000462.
PubMed 29319544Schlenker 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C
- ClinicalTrials.gov ID
- NCT04750447
- Acronym / sponsor ID
- 1035
- Conditions
- Glaucoma, Open-Angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prism Eye InstituteUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Jun 2023 (estimated)
- Study completion
- 9 Jun 2023 (estimated)
- First posted
- 11 Feb 2021 (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.
The Xen gelatin microstent (Allergan, CA, USA) is a 6mm hydrophobic, bleb-forming microinvasive glaucoma surgery (MIGS).1 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. Currently three Xen models have been developed: 45, 63, and 140 um internal lumen diameters.2 XEN45 ab interno gelatin stent was the first to be approved for clinical use in Canada.3 A recent retrospective cohort study showed comparable safety and risk of failure to trabeculectomy.4 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. Recently, the XEN63 ab interno gelatin stent was approved by Health Canada for clinical use in Canada. Being a new device, to date, no study has examined the effect of XEN63 ab interno gelatin stent on anti-glaucoma drops burden and IOP. The aim of this study is to investigate the safety and efficacy of the XEN63 ab interno gelatin stent to provide insights for ophthalmologists who will want to add this technique to their practice.
Detailed description
- This is a prospective, single-arm, open-label clinical trial designed to demonstrate the safety and IOP-lowering effectiveness of XEN 63. Approximately 29 patients who are scheduled to undergo glaucoma surgery with XEN63 implantation will be enrolled and followed for up to 12 months postoperatively. Enrollees will follow the standard of care visits (pre-op, post-op day 1, post-op week 1 and post op month 1) where they will undergo a full eye exam (visual acuity, refraction, slit lamp exam and intraocular pressure measurement). In addition to the standard of care visit, enrollees will have 2 additional visits (post-op month 6 and post-op month 12) where they will undergo a full eye exam. Additional tests include a Visual Field assessment and Endothelial cell count on their pre-op visit, post-operative month visit 6 and post-op month 12 visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Angle Glaucoma | – | Device: XEN 63Patients aged 30-90 Primary open angle glaucoma on maximum tolerated medical therapy Going to receive XEN63 ab interno gelatin stent with or without MMC in study eye ± cataract surgery |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo Xen 63 implantation for open angle glaucoma with or without cataract surgery
Key inclusion criteria (1 listed)
- Patients aged 30-90 Primary open angle glaucoma on maximum tolerated medical therapy Going to receive XEN63 ab interno gelatin stent with or without MMC in study eye ± cataract surgery
Key exclusion criteria (8 listed)
- Other forms of glaucoma
- Previous glaucoma shunt/valve in the target quadrant of study eye
- Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant of study eye
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis), active iris neovascularization or neovascularization of the iris within six months of the surgical date
- Presence of anterior chamber intraocular lens, 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)
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 63The Xen gelatin microstent (Allergan, CA, USA) is a 6mm gelatin tube used in microinvasive glaucoma surgery (MIGS) to create a bleb. A bleb is a fluid filled blister located in the tissue covering the white portion of the eye (the conjunctiva) created after glaucoma surgery. The bleb allows the eye pressure (intraocular pressure - IOP) to be lowered by bypassing the natural pathways by which the fluid called aqueous leaves the eye and redirecting it towards the bleb to be absorbed by other pathways. Amongst the main advantages of this device is the ability to create a bleb without disrupting tissue unlike other methods of glaucoma surgery (e.g., trabeculectomy). This decreases the amount of wound healing and scarring, and potentially limiting bleb failure. | Device | Open Angle Glaucoma |
Primary outcome
Complete Success
Time frame: 1 month post op to post op month 12
Intraocular Pressure: 6-17 mmHg and on no glaucoma medications at least 1 month after surgery with no reoperation using the Goldmann Applanation Tonometer..
Absence of complications
Time frame: post op day 1 to post op month 12
Absence of the following complications as reported during slitlamp examination: i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, 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, blebitis/endophthalmitis
Qualified Success
Time frame: post op month 1 to post op month 12
a. 'Complete success' criteria except that Intraocular Pressure (IOP) can be above IOP thresholds, and then reduced to within the 'Complete criteria' by medications or laser in 3 visits or less as measured by Goldmann Applanation Tonometry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- 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 29319544Green W, Lind JT, Sheybani A. Review of the Xen Gel Stent and InnFocus MicroShunt. Curr Opin Ophthalmol. 2018 Mar;29(2):162-170. doi: 10.1097/ICU.0000000000000462.
- 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.
- 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.
Iqbal 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, Open-Angle, 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 8 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 28 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronaldo Santiago, MD (905-4563937 ext. 267, ronaldo.santiago@prismeye.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Success (time frame: 1 month post op to post op month 12). The study lists 3 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 NCT04750447, which also lists 3 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 28 Sep 2022.