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

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05130554
Collaborator
Allergan (Industry)
20
Enrollment
1
Location
1
Arm
10.7
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: XEN45 gel stent implantation
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Actual Study Start Date :
Nov 7, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: XEN45

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

Procedure: XEN45 gel stent implantation
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.
Other Names:
  • XEN

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IOP (intraocular pressure) changes [3 months after surgery]

      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

    1. BCVA（Best corrected vision ability）changes [Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery]

      Evaluate the patient's BCVA changes before and after surgery

    2. anti-glaucoma drugs changes [Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery]

      Compare the amount of patient's anti-glaucoma drugs before and after surgery

    3. IOP (intraocular pressure) changes [Baseline (before surgery) and 1 day, 1 week, 1 month,6 month and 12 months after surgery]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Allergan

    Investigators

    • Study Chair: Mingkai Lin, M.D,Ph.D, Zhognshan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05130554
    Other Study ID Numbers:
    • 2021KYPJ172
    First Posted:
    Nov 23, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    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

    Study Results

    No Results Posted as of Nov 23, 2021