ACRO Biocornea Clinical Trial in Taiwan

A Multicenter, Open-label, Single-arm Study Assess the Collagen Ophthalmic Matrix for Anterior Lamellar Keratoplasty.

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).

Study Overview

• Status: Completed
• Conditions: Corneal Ulcer
• Intervention / Treatment: Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan
    • Kaohsiung Veterans General Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

1. Inclusion criteria:

1. Male or female from 20 to 80 years old
2. Subject who has been diagnosed with corneal ulcer
3. The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others…)
4. The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates >2 mm diameter, detected by OCT
5. Best corrected vision acuity < 0.05
6. Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up

2. Exclusion criteria:

1. Accepted keratoplasty
2. Has a corneal perforation and expects to have vision
3. Has a severe dry eye
4. Experience s incomplete eyelid closure
5. H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal
6. Has renal function (Cr) levels greater than normal two folders
7. Has serum protein 10% low than normal
8. Has severe cardiovascular and cerebral vascular disease
9. Subject with uncontrolled diabetes
10. Subject with current malignancy
11. Known to be allergic to collagen
12. Has a systemic collagen connective tissue disease
13. Has a constitution prone to severe allergic reactions
14. Use s anticoagulants 5 days before studying keratoplasty
15. Use s injectable NSAID 3 days before studying keratoplasty
16. Cannot accept investigated material due to religious or cultural reason
17. Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant
18. Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form;
19. Not being considered suitable for this study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After the surgery, patients will be examined for follow-up observation for 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24-week follow-up visit. Totoa 9 times.
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.	24-week follow-up visit. Totoa 9 times.
Infection recurrence	The recurrence was examined via slit lamp by the clinical ophthalmologist.	24-week follow-up visit. Totoa 9 times.
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.	24-week follow-up visit. Totoa 9 times.
Best corrected vision acuity	Examied by the Optometer.	24-week follow-up visit. Totoa 9 times.
Light sensitivity	The light perception was tested by the clinical ophthalmologist.	24-week follow-up visit. Totoa 9 times.

Collaborators and Investigators

• Sponsor: ACRO Biomedical Co. Ltd
• Investigators: Principal Investigator: Ming-Cheng TAI, MD, Tri-Service General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Keratitis; Corneal Diseases; Eye Infections; Corneal Ulcer
• Other Study ID Numbers: AC-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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