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Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

Primary Purpose

Corneal Ulcer, Leukoma

Status

Completed

Phase

Not Applicable

Locations

Ukraine

Study Type

Interventional

Intervention

Collagen-MPC cornea

About this trial

This is an interventional treatment trial for Corneal Ulcer

Eligibility Criteria

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

Inclusion Criteria:

Subjects must sign and be given a copy of the written Informed Consent form.
Subjects with best corrected distance visual acuity 20/200 or worse as a result of corneal ulcer or corneal scar due to burn, injury or infection in the operative eye.
Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

Exclusion Criteria:

Subjects with severe or life-threatening systemic disease.
Subjects with uncontrolled hypertension.
Subjects with uncontrolled diabetes or insulin-dependent diabetes.
Subjects with glaucoma in either eye.
Subjects with marked microphthalmos or aniridia in either eye.
Subjects with any other serious ocular pathology, serious ocular complications at the time of corneal transplant underlying serious medical conditions, based on the investigator's medical judgment.
Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.

Sites / Locations

The Filatov Institute of Eye Diseases and Tissue Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collagen-MPC cornea substitute

Arm Description

Collagen-phosphorylcholine (collagen-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Implant safety and tolerability will be measured by absence/presence of its lysis as well as by degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom.

Secondary Outcome Measures

Number of Participants With Healed Cornea at 12 Months

Cornea is considered to have healed up when there is no defect of corneal epithelium, which is confirmed by fluorescein staining of corneal surface

Number of Participants With Improved Visual Acuity at 12 Months

Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity

Full Information

NCT ID

NCT02277054

First Posted

October 26, 2014

Last Updated

October 25, 2018

Sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Collaborators

Linkoeping University

1. Study Identification

Unique Protocol Identification Number

NCT02277054

Brief Title

Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

Official Title

A Clinical Trial to Evaluate the Safety and Effectiveness of the Collagen-phosphorylcholine Corneal Substitutes in Patients Requiring Lamellar Keratoplasty

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Collaborators

Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this study the safety and effectiveness of biosynthetic cornea, comprising interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested in patients with severe corneal pathology (corneal ulcers or corneal opacification from corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the only widely accepted treatment) carries a high risk of rejection.

Detailed Description

Collagen-phosphorylcholine corneal substitute will be implanted in patient's corneas with severe pathology (corneal ulcer, corneal leukoma after burn, trauma or infection) using anterior lamellar keratoplasty technique, i.e. when patient's diseased cornea is removed it will be substituted with proposed transparent implant. Usually these patients are grafted with human donor cornea, but the latter frequently fails due to graft-versus-host problems. We will test the safety (incidence of adverse events, biocompatability) and the effectiveness (ability to promote healing and increase vision) of developed biosynthetic corneas in 10 patients with corneal pathology, where human donor cornea carries a high risk of rejection. The patients will be follow-uped for 12 months.

6. Conditions and Keywords

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

Corneal Ulcer, Leukoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Collagen-MPC cornea substitute

Arm Type

Experimental

Arm Description

Collagen-phosphorylcholine (collagen-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.

Intervention Type

Device

Intervention Name(s)

Collagen-MPC cornea

Intervention Description

Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection will be created. Trephine diameter will depend on ulcer or leukoma maximal size. Alternatively a femtosecond laser may be used to create the dissection. A collagen-phosphorylcholine cornea 250-500 microns thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of Participants With Healed Cornea at 12 Months

Description

Cornea is considered to have healed up when there is no defect of corneal epithelium, which is confirmed by fluorescein staining of corneal surface

Time Frame

12 months

Title

Number of Participants With Improved Visual Acuity at 12 Months

Description

Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must sign and be given a copy of the written Informed Consent form. Subjects with best corrected distance visual acuity 20/200 or worse as a result of corneal ulcer or corneal scar due to burn, injury or infection in the operative eye. Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery. Exclusion Criteria: Subjects with severe or life-threatening systemic disease. Subjects with uncontrolled hypertension. Subjects with uncontrolled diabetes or insulin-dependent diabetes. Subjects with glaucoma in either eye. Subjects with marked microphthalmos or aniridia in either eye. Subjects with any other serious ocular pathology, serious ocular complications at the time of corneal transplant underlying serious medical conditions, based on the investigator's medical judgment. Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nataliya Pasyechnikova, MD, PhD, DSc

Organizational Affiliation

The Filatov Institute of Eye Diseases and Tissue Therapy

Official's Role

Study Director

Facility Information:

Facility Name

The Filatov Institute of Eye Diseases and Tissue Therapy

City

Odessa

ZIP/Postal Code

65061

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19097643

Citation

Liu W, Deng C, McLaughlin CR, Fagerholm P, Lagali NS, Heyne B, Scaiano JC, Watsky MA, Kato Y, Munger R, Shinozaki N, Li F, Griffith M. Collagen-phosphorylcholine interpenetrating network hydrogels as corneal substitutes. Biomaterials. 2009 Mar;30(8):1551-9. doi: 10.1016/j.biomaterials.2008.11.022. Epub 2008 Dec 20.

Results Reference

result

PubMed Identifier

20847116

Citation

Hackett JM, Lagali N, Merrett K, Edelhauser H, Sun Y, Gan L, Griffith M, Fagerholm P. Biosynthetic corneal implants for replacement of pathologic corneal tissue: performance in a controlled rabbit alkali burn model. Invest Ophthalmol Vis Sci. 2011 Feb 3;52(2):651-7. doi: 10.1167/iovs.10-5224.

Results Reference

result

Learn more about this trial

Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

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