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ACRO Biocornea Clinical Trial in Taiwan

Primary Purpose

Corneal Ulcer

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

About this trial

This is an interventional treatment trial for Corneal Ulcer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female from 20 to 80 years old
Subject who has been diagnosed as fungal keratitis by culture or dyeing or PCR or confocal microscope
No response over a period of 2 weeks of Amphotericin B or Triazoles or Natamycin treatment, and the depth or the size of ulcer increases or increased anterior chamber inflammation
The keratitis affect corneal stroma depth to 1/2~2/3 and infiltrate >2 mm diameter, detected by OCT
Best corrected vision acuity < 0.05
Subject who signs the informed consent form (ICF), and agree to complete the treatment and follow-up

Exclusion Criteria:

Accepted keratoplasty
Has a corneal perforation and expect to have vision
Has severe dry eye
Experiences incomplete eyelid closure
Has liver function (ALT and AST) tests with score as two fold or greater as that of the normal
Has renal function (Cr) levels greater than normal two folders
Has serum protein 10% low than normal
Has severe cardiovascular and cerebral vascular disease
Has diabetes
Has a tumor
Known to be allergic to collagen
Has a systemic collagen connective tissue disease
Has a constitution prone to severe allergic reactions
Uses anticoagulants 5 days before screening
Uses topical/oral/injectable NSAID 14 days before screening
Cannot accept investigated material due to religion or culture reason
Pregnant or breast-feeding women or childbearing-age women who plans to get pregnant
Participates in other drug or medical instrument clinical trials in the last 12 weeks
Not being considered suitable for this study by the investigator

Sites / Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital
Tri-Service General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Infection recurrence

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

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.

Best corrected vision acuity

Examied by the Optometer.

Light sensitivity

The light perception was tested by the clinical ophthalmologist.

Full Information

NCT ID

NCT04054817

First Posted

August 9, 2019

Last Updated

April 17, 2023

Sponsor

ACRO Biomedical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04054817

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

October 5, 2022 (Actual)

Study Completion Date

March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ACRO Biomedical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix

Other Intervention Name(s)

ACRO Biocornea

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months.

Description

Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate

Time Frame

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

Secondary Outcome Measure Information:

Title

The extent of graft transparency

Description

Time Frame