ACRO Biocornea Clinical Trial in Taiwan

Corneal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054817
• Other study ID #: AC-2017-01
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: March 6, 2023

Study information

• Verified date: April 2023
• Source: ACRO Biomedical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 6, 2023
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Ulcer

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
ACRO Biomedical Co. Ltd

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

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