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Corneal UlcerNCT04054817

ACRO Biocornea Clinical Trial in Taiwan

A study testing Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix in people with Corneal Ulcer, run by ACRO Biomedical Co. Ltd at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Corneal Ulcer
What is being tested?
Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesTaiwan
Study dates
2 Nov 2020to 6 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion criteria:
  2. Male or female from 20 to 80 years old
  3. Subject who has been diagnosed with corneal ulcer
  4. The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others…)
  5. The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates >2 mm diameter, detected by OCT
  6. Best corrected vision acuity < 0.05
  7. Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up
  8. Exclusion criteria:
  9. Accepted keratoplasty
  10. Has a corneal perforation and expects to have vision
  11. Has a severe dry eye
  12. Experience s incomplete eyelid closure
  13. H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal
  14. Has renal function (Cr) levels greater than normal two folders
  15. Has serum protein 10% low than normal
  16. Has severe cardiovascular and cerebral vascular disease
  17. Subject with uncontrolled diabetes
  18. Subject with current malignancy
  19. Known to be allergic to collagen
  20. Has a systemic collagen connective tissue disease
  21. Has a constitution prone to severe allergic reactions
  22. Use s anticoagulants 5 days before studying keratoplasty
  23. Use s injectable NSAID 3 days before studying keratoplasty
  24. Cannot accept investigated material due to religious or cultural reason
  25. Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant
  26. Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form;
  27. Not being considered suitable for this study by the investigator

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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).

Conditions
Corneal Ulcer
Being tested
Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
Medical subject headings
Corneal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic MatrixDevice

    Also called ACRO Biocornea

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

Study groups in NCT04054817
Study groupRoleWhat they receive
Single ArmExperimentalNot described
Receives: Device: Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: After the surgery, patients will be examined for follow-up observation for 24 weeks.

Secondary outcomes (6)

  1. 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.

    Measured: 24-week follow-up visit. Totoa 9 times.

  2. 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.

    Measured: 24-week follow-up visit. Totoa 9 times.

  3. Infection recurrence

    The recurrence was examined via slit lamp by the clinical ophthalmologist.

    Measured: 24-week follow-up visit. Totoa 9 times.

  4. 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.

    Measured: 24-week follow-up visit. Totoa 9 times.

  5. Best corrected vision acuity

    Examied by the Optometer.

    Measured: 24-week follow-up visit. Totoa 9 times.

  6. Light sensitivity

    The light perception was tested by the clinical ophthalmologist.

    Measured: 24-week follow-up visit. Totoa 9 times.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start2 Nov 2020
  3. Primary completion5 Oct 2022
  4. Study completion6 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04054817
Sponsor's protocol ID
AC-2017-01
Status last verified
Apr 2023
First submitted
9 Aug 2019
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28579539

Questions about this trial

What is this clinical trial studying?

A study testing Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix in people with Corneal Ulcer, run by ACRO Biomedical Co. Ltd at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months. (time frame: After the surgery, patients will be examined for follow-up observation for 24 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04054817, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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