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XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma

Primary Purpose

Glaucoma, Glaucoma, Open-Angle, Surgery

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
XEN45 gel stent implantation
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients diagnosed with POAG;
  2. The visual acuity of the affected eye is greater than that of manual operation;
  3. Between 18 and 90 years old;
  4. No surgery or laser treatment within 90 days;
  5. Patients with other types of glaucoma whose intraocular pressure has not been controlled by traditional surgery or medication;
  6. The target quadrant has healthy conjunctiva and free movement without scars.

Exclusion Criteria:

  1. Angle-closure glaucoma;
  2. Active uveitis;
  3. Any corneal disease;
  4. Patients with eye infections two weeks before the operation;
  5. During pregnancy or lactation;
  6. Active neovascular glaucoma;
  7. Known or suspected allergy or sensitivity to pig products or glutaraldehyde.

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XEN45

Arm Description

The effect of XEN45 surgery on patients with primary open-angle glaucoma

Outcomes

Primary Outcome Measures

IOP (intraocular pressure) changes
Compare the patient's IOP changes before and after surgery. Complete success of the operation was defined as IOP≤21mmhg without any glaucoma drugs. Qualified success is defined as the same intraocular pressure level but with medication. Failure is defined as IOP> 21 mmHg and maximum tolerance of the drug

Secondary Outcome Measures

BCVA(Best corrected vision ability)changes
Evaluate the patient's BCVA changes before and after surgery
anti-glaucoma drugs changes
Compare the amount of patient's anti-glaucoma drugs before and after surgery
IOP (intraocular pressure) changes
Compare the patient's IOP changes before and after surgery. Complete success of the operation was defined as IOP≤21mmhg without any glaucoma drugs. Qualified success is defined as the same intraocular pressure level but with medication. Failure is defined as IOP> 21 mmHg and maximum tolerance of the drug

Full Information

First Posted
November 6, 2021
Last Updated
November 22, 2021
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT05130554
Brief Title
XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Official Title
XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 7, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborators
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Glaucoma is the second most common blindness disease in the world, second only to cataracts. The current treatment of glaucoma is mainly to reduce intraocular pressure.At present, two commonly used surgical methods are trabeculectomy and implantation of drainage valve. These methods are superior to drug treatment in reducing intraocular pressure, but the effect duration of these two methods is not long, and there may be serious complications and failure. Compared with traditional glaucoma surgery, MIGS may have better safety.The XEN45 gel implant is a collagen tube with a length of 6 mm and a diameter of 45 µm, which creates a new channel for drainage of aqueous humor by connecting the anterior chamber and the subconjunctival space. The implant is composed of porcine gelatin cross-linked with glutaraldehyde, and has good biocompatibility and tolerance. Therefore, after the advent of XEN45 products, more and more studies have shown that this treatment has excellent safety and effectiveness in reducing intraocular pressure in patients with open-angle glaucoma. Considering that the XEN45 gel stent has been in the market for a relatively short time, we conducted this prospective study to investigate the effect of XEN45 surgery in the treatment of primary open-angle glaucoma, in order to support ophthalmologists in formulating the best surgical plan for patients. The promotion of this surgical method.
Detailed Description
Observation index: The visual acuity, intraocular pressure, slit lamp, ophthalmoscope, traditional vision, UBM and anti-glaucoma drugs before surgery and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open-Angle, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XEN45
Arm Type
Experimental
Arm Description
The effect of XEN45 surgery on patients with primary open-angle glaucoma
Intervention Type
Procedure
Intervention Name(s)
XEN45 gel stent implantation
Other Intervention Name(s)
XEN
Intervention Description
The XEN45 gel implant is a collagen tube with a length of 6 mm and a diameter of 45 µm, which creates a new channel for drainage of aqueous humor by connecting the anterior chamber and the subconjunctival space. The implant is composed of porcine gelatin cross-linked with glutaraldehyde, and has good biocompatibility and tolerance.This treatment method has excellent safety and effectiveness in reducing the intraocular pressure of patients with open-angle glaucoma. At the same time, the operation is simple and safe.
Primary Outcome Measure Information:
Title
IOP (intraocular pressure) changes
Description
Compare the patient's IOP changes before and after surgery. Complete success of the operation was defined as IOP≤21mmhg without any glaucoma drugs. Qualified success is defined as the same intraocular pressure level but with medication. Failure is defined as IOP> 21 mmHg and maximum tolerance of the drug
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
BCVA(Best corrected vision ability)changes
Description
Evaluate the patient's BCVA changes before and after surgery
Time Frame
Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
Title
anti-glaucoma drugs changes
Description
Compare the amount of patient's anti-glaucoma drugs before and after surgery
Time Frame
Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
Title
IOP (intraocular pressure) changes
Description
Compare the patient's IOP changes before and after surgery. Complete success of the operation was defined as IOP≤21mmhg without any glaucoma drugs. Qualified success is defined as the same intraocular pressure level but with medication. Failure is defined as IOP> 21 mmHg and maximum tolerance of the drug
Time Frame
Baseline (before surgery) and 1 day, 1 week, 1 month,6 month and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with POAG; The visual acuity of the affected eye is greater than that of manual operation; Between 18 and 90 years old; No surgery or laser treatment within 90 days; Patients with other types of glaucoma whose intraocular pressure has not been controlled by traditional surgery or medication; The target quadrant has healthy conjunctiva and free movement without scars. Exclusion Criteria: Angle-closure glaucoma; Active uveitis; Any corneal disease; Patients with eye infections two weeks before the operation; During pregnancy or lactation; Active neovascular glaucoma; Known or suspected allergy or sensitivity to pig products or glutaraldehyde.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingkai Lin, M.D,Ph.D
Organizational Affiliation
Zhognshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma

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