Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: XEN 63

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Ronaldo Santiago, MD; Phone Number: 267 905-4563937; Email: ronaldo.santiago@prismeye.ca
• Study Contact Backup: Name: Ramzi Jumaa, MD; Phone Number: 267 905-456-3937; Email: ramzi3@gmail.com

Study Locations

• Canada
  • Ontario
    • Oakville, Ontario, Canada, L6H 0J8
      • Recruiting
      • Prism Eye Institute
      • Contact: Ronaldo Santiago, MD; Phone Number: 267 (905) 456-3937; Email: ike.research@prismeye.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo Xen 63 implantation for open angle glaucoma with or without cataract surgery

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: XEN 63; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..	1 month post op to post op month 12
Absence of complications	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	post op day 1 to post op month 12
Qualified Success	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.	post op month 1 to post op month 12

Collaborators and Investigators

• Sponsor: Prism Eye Institute
• Collaborators: Allergan
• Investigators: Principal Investigator: Iqbal Ahmed, MD, Prism Eye Institute

Publications and helpful links

General 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.
• Green 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. Review.
• 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. Erratum In: Ophthalmology. 2018 Mar;125(3):463.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Anticipated): June 9, 2023
• Study Completion (Anticipated): June 9, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 1035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes