Clincosm LogoSign in Get a demo

ACRO Biocornea Clinical Trial in Taiwan

Sponsor
ACRO Biomedical Co. Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04054817
Collaborator
(none)
8
Enrollment
4
Locations
1
Arm
19.7
Anticipated Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose:

Investigate the safety of ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients suffering from fungal keratitis which cannot be treated with drugs.

Investigational medical device:

  1. Product name: ABCcolla Collagen Ophthalmic Matrix

  2. Manufacturer: ACRO Biomedical Co., Ltd.

  3. Address of manufacturer: 3rd Floor, No.57, Luke 2nd Rd., Lujhu District, Kaohsiung City 82151, Taiwan (R.O.C.)

  4. Indication: to replace human cornea in anterior lamellar keratoplasty

  5. Classification: Class III

Study overview:

Each volunteer will be assigned a set of subject screening No. after signing the ICF. After review of basic information and medical and drug history, screening of inclusion and exclusion criteria and relevant assessment and record, the doctor will make the final decision of whether to enroll the subject. Enrolled subjects will be assigned a subject enrollment No. They will undergo keratoplasty using the investigational product and be followed up for observation. Subjects are required to complete 9 visits (V2~V10) and will be followed up for 24 weeks.

Condition or Disease Intervention/Treatment Phase
  • Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Open-label, Single-arm Study Assess the Collagen Ophthalmic Matrix for Anterior Lamellar Keratoplasty
Actual Study Start Date :
May 11, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.
Other Names:
  • ACRO Biocornea

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months. [After surgery, the patient will be assesed on day 3, 7, 14. After that patients will be evaluated at every 4 weeks for 24 weeks.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female from 20 to 80 years old

    • Subject who has been diagnosed as fungal keratitis by culture or dyeing or PCR or confocal microscope

    • No response over a period of 2 weeks of Amphotericin B or Triazoles or Natamycin treatment, and the depth or the size of ulcer increases or increased anterior chamber inflammation

    • The keratitis affect corneal stroma depth to 1/2~2/3 and infiltrate >2 mm diameter, detected by OCT

    • Best corrected vision acuity < 0.05

    • Subject who signs the informed consent form (ICF), and agree to complete the treatment and follow-up

    Exclusion Criteria:

    • Accepted keratoplasty

    • Has a corneal perforation and expect to have vision

    • Has severe dry eye

    • Experiences incomplete eyelid closure

    • Has liver function (ALT and AST) tests with score as two fold or greater as that of the normal

    • Has renal function (Cr) levels greater than normal two folders

    • Has serum protein 10% low than normal

    • Has severe cardiovascular and cerebral vascular disease

    • Has diabetes

    • Has a tumor

    • Known to be allergic to collagen

    • Has a systemic collagen connective tissue disease

    • Has a constitution prone to severe allergic reactions

    • Uses anticoagulants 5 days before screening

    • Uses topical/oral/injectable NSAID 14 days before screening

    • Cannot accept investigated material due to religion or culture reason

    • Pregnant or breast-feeding women or childbearing-age women who plans to get pregnant

    • Participates in other drug or medical instrument clinical trials in the last 12 weeks

    • Not being considered suitable for this study by the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan
    2 Kaohsiung Veterans General Hospital Kaohsiung Taiwan
    3 Taipei Veterans General Hospital Taipei Taiwan
    4 Tri-Service General Hospital Taipei Taiwan

    Sponsors and Collaborators

    • ACRO Biomedical Co. Ltd

    Investigators

    • Principal Investigator: Ming-Cheng Tai, MD, Tri-Service General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ACRO Biomedical Co. Ltd
    ClinicalTrials.gov Identifier:
    NCT04054817
    Other Study ID Numbers:
    • AC-2017-01
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Aug 14, 2019
    Last Verified:
    Aug 1, 2019
    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
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Keratitis

    Study Results

    No Results Posted as of Aug 14, 2019