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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Open-angle Glaucoma
• Intervention / Treatment: Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland, 54-622
    • Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: stand-alone procedure of XEN implantation in phakic eyes	Drug: 5-fluorouracil; 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.; Procedure: Transconjunctival needling; Transconjunctival needling was administered according to predetermined criteria.; Procedure: Transconjunctival revision; Transconjunctival revision was administered according to predetermined criteria.
Active Comparator: stand-alone procedure of XEN implantation in pseudophakic eyes	Drug: 5-fluorouracil; 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.; Procedure: Transconjunctival needling; Transconjunctival needling was administered according to predetermined criteria.; Procedure: Transconjunctival revision; Transconjunctival revision was administered according to predetermined criteria.
Active Comparator: XEN implantation combined with cataract extraction	Drug: 5-fluorouracil; 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.; Procedure: Transconjunctival needling; Transconjunctival needling was administered according to predetermined criteria.; Procedure: Transconjunctival revision; Transconjunctival revision was administered according to predetermined criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glaucoma Progression	Glaucoma progression was evaluated with the Hodapp-Parrish-Anderson Glaucoma Grading Scale (GGS). Staging according to the standards given in bibliography (Budenz et all in 2002)	5 years
Change in thickness of the retinal nerve fiber layer (RNFL)	Difference in thickness of the retinal nerve fiber layer during the observation time frame.	5 years
Change in thickness of ganglion cell complex (GCC)	Difference in thickness of ganglion cell complex during the observation time frame.	5 years
Short term changes in IOP after surgery	Evaluated with the use of water drinking test.	5 years
Refractive error	Change in refractive error after glaucoma procedures	5 years
Best-corrected visual acuity	Evaluated on the fixed charts by trained optometrist	5 years
Visual field (VF)	Detection of the visual field abnormalities on the standard machine and during screening procedures	5 years
Disc damage likelihood scale (DDLS)	Evaluation disc damage likelihood scale based on the fundus photographs	5 years
Peripapillar and macular vessels density	Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA)	5 years

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Collaborators: Wrocław University of Science and Technology
• Investigators: Principal Investigator: Ewa Wałek, Medical University of Wrocław

Publications and helpful links

General 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.
• Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil
• Other Study ID Numbers: STM.C240.17.037

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: No