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

Primary Purpose

Open-angle Glaucoma

Status

Active

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

5-fluorouracil

Transconjunctival needling

Transconjunctival revision

About this trial

This is an interventional health services research trial for Open-angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

stand-alone procedure of XEN implantation in phakic eyes

stand-alone procedure of XEN implantation in pseudophakic eyes

XEN implantation combined with cataract extraction

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03904381

First Posted

April 3, 2019

Last Updated

March 27, 2022

Sponsor

Wroclaw Medical University

Collaborators

Wrocław University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT03904381

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wroclaw Medical University

Collaborators

Wrocław University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-angle Glaucoma

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

stand-alone procedure of XEN implantation in phakic eyes

Arm Type

Active Comparator

Arm Title

stand-alone procedure of XEN implantation in pseudophakic eyes

Arm Type

Active Comparator

Arm Title

XEN implantation combined with cataract extraction

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil

Intervention Description

5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

Intervention Type

Procedure

Intervention Name(s)

Transconjunctival needling

Intervention Description

Transconjunctival needling was administered according to predetermined criteria.

Intervention Type

Procedure

Intervention Name(s)

Transconjunctival revision

Intervention Description

Transconjunctival revision was administered according to predetermined criteria.

Primary Outcome Measure Information:

Title

Unqualified success

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Qualified success score A

Description

Time Frame

5 years

Title

Qualified success score B

Description

Time Frame

5 years

Title

Qualified success score C

Description

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Glaucoma Progression

Description

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)

Time Frame

5 years

Title

Change in thickness of the retinal nerve fiber layer (RNFL)

Description

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

Time Frame

5 years

Title

Change in thickness of ganglion cell complex (GCC)

Description

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

Time Frame

5 years

Title

Short term changes in IOP after surgery

Description

Evaluated with the use of water drinking test.

Time Frame

5 years

Title

Refractive error

Description

Change in refractive error after glaucoma procedures

Time Frame

5 years

Title

Best-corrected visual acuity

Description

Evaluated on the fixed charts by trained optometrist

Time Frame

5 years

Title

Visual field (VF)

Description

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

Time Frame

5 years

Title

Disc damage likelihood scale (DDLS)

Description

Evaluation disc damage likelihood scale based on the fundus photographs

Time Frame

5 years

Title

Peripapillar and macular vessels density

Description

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

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marta Misiuk-Hojło, Professor

Organizational Affiliation

Medical University of Wrocław

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ewa Wałek

Organizational Affiliation

Medical University of Wrocław

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Ophthalmology

City

Wrocław

ZIP/Postal Code

54-622

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12215086

Citation

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.

Results Reference

background

PubMed Identifier

19834563

Citation

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

Results Reference

background

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

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