ACRO Biocornea Clinical Trial in Taiwan
Primary Purpose
Corneal Ulcer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Ulcer
Eligibility Criteria
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
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Kaohsiung Veterans General Hospital
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate
Secondary Outcome Measures
The extent of graft transparency
After examined via slit lamp by the clinical ophthalmologist, the graft transparency were graded from 0 to 4, which indicated transparency, slight turbidity, mild turbidity of matrix and visble iris, worsening turbidity with invisible iris, and invisible pupil, respectively.
The extent of graft vascularization
After examined via slit lamp by the clinical ophthalmologist, the extent of neovascularization was grades 0 if there were none, 1-4 if neovascularization had grown into the corneal limbus, the border of graft, 2mm of the gtaft, and into the center of the graft, respectively.
Infection recurrence
The recurrence was examined via slit lamp by the clinical ophthalmologist.
The extend of corneal edema
After examined via OCT by the clinical ophthalmologist, the corneal edema were graded from none, mild, moderate and severe by the doctor.
Best corrected vision acuity
Examied by the Optometer.
Light sensitivity
The light perception was tested by the clinical ophthalmologist.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04054817
Brief Title
ACRO Biocornea Clinical Trial in Taiwan
Official Title
A Multicenter, Open-label, Single-arm Study Assess the Collagen Ophthalmic Matrix for Anterior Lamellar Keratoplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
March 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACRO Biomedical Co. Ltd
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to investigate the safety and clinical performance of ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients suffering from corneal ulcer.
Participants will undergo keratoplasty using the investigational product and be followed up for 24-week observation (total of 10 times).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
Other Intervention Name(s)
ACRO Biocornea
Intervention Description
Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.
Primary Outcome Measure Information:
Title
Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
Description
Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate
Time Frame
After the surgery, patients will be examined for follow-up observation for 24 weeks.
Secondary Outcome Measure Information:
Title
The extent of graft transparency
Description
After examined via slit lamp by the clinical ophthalmologist, the graft transparency were graded from 0 to 4, which indicated transparency, slight turbidity, mild turbidity of matrix and visble iris, worsening turbidity with invisible iris, and invisible pupil, respectively.
Time Frame
24-week follow-up visit. Totoa 9 times.
Title
The extent of graft vascularization
Description
After examined via slit lamp by the clinical ophthalmologist, the extent of neovascularization was grades 0 if there were none, 1-4 if neovascularization had grown into the corneal limbus, the border of graft, 2mm of the gtaft, and into the center of the graft, respectively.
Time Frame
24-week follow-up visit. Totoa 9 times.
Title
Infection recurrence
Description
The recurrence was examined via slit lamp by the clinical ophthalmologist.
Time Frame
24-week follow-up visit. Totoa 9 times.
Title
The extend of corneal edema
Description
After examined via OCT by the clinical ophthalmologist, the corneal edema were graded from none, mild, moderate and severe by the doctor.
Time Frame
24-week follow-up visit. Totoa 9 times.
Title
Best corrected vision acuity
Description
Examied by the Optometer.
Time Frame
24-week follow-up visit. Totoa 9 times.
Title
Light sensitivity
Description
The light perception was tested by the clinical ophthalmologist.
Time Frame
24-week follow-up visit. Totoa 9 times.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
1. Inclusion criteria:
Male or female from 20 to 80 years old
Subject who has been diagnosed with corneal ulcer
The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others…)
The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates >2 mm diameter, detected by OCT
Best corrected vision acuity < 0.05
Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up
2. Exclusion criteria:
Accepted keratoplasty
Has a corneal perforation and expects to have vision
Has a severe dry eye
Experience s incomplete eyelid closure
H as liver function (ALT and AST) tests with the score as twofold or greater than 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
Subject with uncontrolled diabetes
Subject with current malignancy
Known to be allergic to collagen
Has a systemic collagen connective tissue disease
Has a constitution prone to severe allergic reactions
Use s anticoagulants 5 days before studying keratoplasty
Use s injectable NSAID 3 days before studying keratoplasty
Cannot accept investigated material due to religious or cultural reason
Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant
Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form;
Not being considered suitable for this study by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Cheng Tai, MD
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28579539
Citation
Huang YH, Tseng FW, Chang WH, Peng IC, Hsieh DJ, Wu SW, Yeh ML. Preparation of acellular scaffold for corneal tissue engineering by supercritical carbon dioxide extraction technology. Acta Biomater. 2017 Aug;58:238-243. doi: 10.1016/j.actbio.2017.05.060. Epub 2017 Jun 1.
Results Reference
result
Learn more about this trial
ACRO Biocornea Clinical Trial in Taiwan
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