ACRO Biocornea Clinical Trial in Taiwan

NCT ID: NCT04054817

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2023-03-06

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).

Conditions

Corneal Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

Intervention Type: DEVICE

Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ACRO Biocornea

Eligibility Criteria

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACRO Biomedical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Cheng Tai, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 28579539 (View on PubMed)

Other Identifiers

AC-2017-01

Identifier Type: -

Identifier Source: org_study_id