Clinical trial NCT04054817: 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
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Ulcer
Lead sponsor: ACRO Biomedical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.
timeFrame: After the surgery, patients will be examined for follow-up observation for 24 weeks.
Secondary outcomes:
measure: The extent of graft transparency
timeFrame: 24-week follow-up visit. Totoa 9 times.
measure: The extent of graft vascularization
timeFrame: 24-week follow-up visit. Totoa 9 times.
measure: Infection recurrence
timeFrame: 24-week follow-up visit. Totoa 9 times.
measure: The extend of corneal edema
timeFrame: 24-week follow-up visit. Totoa 9 times.
measure: Best corrected vision acuity
timeFrame: 24-week follow-up visit. Totoa 9 times.
measure: Light sensitivity
timeFrame: 24-week follow-up visit. Totoa 9 times.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Ming-Cheng Tai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.