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

• Sponsor: Wroclaw Medical University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03904381
• Collaborator: Wrocław University of Science and Technology (Other)
• Enrollment: 100
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 108
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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)
• Actual Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Unqualified success [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.

Secondary Outcome Measures

1. Qualified success score A [5 years]

   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.

2. Qualified success score B [5 years]

   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.

3. Qualified success score C [5 years]

   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.

Other Outcome Measures

1. Glaucoma Progression [5 years]

   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)

2. Change in thickness of the retinal nerve fiber layer (RNFL) [5 years]

   Difference in thickness of the retinal nerve fiber layer during the observation time frame.

3. Change in thickness of ganglion cell complex (GCC) [5 years]

   Difference in thickness of ganglion cell complex during the observation time frame.

4. Short term changes in IOP after surgery [5 years]

   Evaluated with the use of water drinking test.

5. Refractive error [5 years]

   Change in refractive error after glaucoma procedures

6. Best-corrected visual acuity [5 years]

   Evaluated on the fixed charts by trained optometrist

7. Visual field (VF) [5 years]

   Detection of the visual field abnormalities on the standard machine and during screening procedures

8. Disc damage likelihood scale (DDLS) [5 years]

   Evaluation disc damage likelihood scale based on the fundus photographs

9. Peripapillar and macular vessels density [5 years]

   Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology	Wrocław		Poland	54-622

Sponsors and Collaborators

• Wroclaw Medical University
• Wrocław University of Science and Technology

Investigators

• Study Chair: Marta Misiuk-Hojło, Professor, Medical University of Wrocław
• Principal Investigator: Ewa Wałek, Medical University of Wrocław

Study Documents (Full-Text)

None provided.

More Information

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

• Responsible Party: Joanna Przeździecka-Dołyk, Investigator, Wroclaw Medical University
• ClinicalTrials.gov Identifier: NCT03904381
• Other Study ID Numbers: STM.C240.17.037
• First Posted: Apr 5, 2019
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Fluorouracil

Study Results

No Results Posted as of Mar 29, 2022