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Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus (LinkCor)

Primary Purpose

Keratoconus

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

LinkCor Bioengineered Corneal Implant

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring corneal blindness, keratoconus, bioengineered cornea, intrastromal implantation, femtosecond laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Advanced keratoconus (according to Amsler-Krumeich classification)
No corneal scar
Male or female aged ≥ 18 years, no upper age limit
Subjects indicated for a first corneal stromal transplantation (treatment naïve)
Corneal thickness (including epithelium) at least 300µm centrally, as measured by OCT.
Patients who gave their written signed and dated informed consent for participation

Exclusion Criteria:

Prior corneal surgery (e.g., refractive surgery, cataract, collagen cross-linking, endothelial keratoplasty, etc.)
Dry eye / tear film pathology
Active ocular infection
Glaucoma / ocular hypertension
Active corneal ulceration
Acute or chronic disease or illness that would increase the operation risk or confound the outcomes of the study (immune- compromised, connective tissue disease, clinically significant atopic disease, etc.)
Any other medical condition that in the judgment of the clinical investigator or corneal surgeon is not compatible with the study procedures
General history judged by the investigator to be incompatible with the study (e.g., life-threatening patient condition, other condition where postoperative follow-up may be difficult).
known diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing)
Inability of patient to understand the study procedures and thus inability to give informed consent.
Participation in another clinical study within the last 3 months
Already included once in this study (can only be included for one treated eye).

Sites / Locations

All India Institute of Medical Sciences, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS,Recruiting
Farabi Eye Hospital, Tehran University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bioengineered corneal substitute

Arm Description

A cell-free, sterilized bioengineered corneal substitute made from medical grade collagen

Outcomes

Primary Outcome Measures

Safety outcome measure

The primary safety endpoint is defined such that a rejection leading to implant removal should occur in no more than 10% of implanted eyes. The implant rejection is defined as a clinical situation when the implanted eye has decreased central corneal clarity and decreased implant clarity, corneal vascularization inside of laser created pocket and inflammation.

Corneal curvature measured by keratometry (efficacy measure)

The maximum and minimum corneal curvature (steepness) of each eye will be measured by a keratometer and reported in diopter (D) unit and represented as "K-value". The efficacy outcome is that more than 60% of the eyes should have a decrease in K-value at 6 months postoperatively.

Central corneal thickness measured by topography techniques (efficacy measure)

Central corneal thickness (CCT) will be measured in microns and reported using a two-dimensional thickness map made by optical coherence tomography (OCT) and/or Pentacam topography. The efficacy outcome is that more than 60% of the eyes should have an increase in CCT at 6 months postoperatively.

Visual acuity (efficacy measure)

Vision improvement equivalent of minimum one line in Snellen chart in uncorrected distance visual acuity (UDVA) or corrected distance visual acuity (CDVA).

Secondary Outcome Measures

Full Information

NCT ID

NCT04653922

First Posted

November 23, 2020

Last Updated

March 8, 2023

Sponsor

LinkoCare Life Sciences AB

1. Study Identification

Unique Protocol Identification Number

NCT04653922

Brief Title

Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus

Acronym

LinkCor

Official Title

Evaluation of Safety and Efficacy of Intrastromal Implantation of LinkCor Bioengineered Corneal Implant for Management and Treatment of Keratoconus: a Prospective, Non-randomized, Non-controlled Case Series.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 2016 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LinkoCare Life Sciences AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective, Phase I open-label safety study to evaluate the safety, feasibility and initial efficacy of a bioengineered corneal stromal substitute after implantation into the stroma of adults with advanced keratoconus. The bioengineered substitute and implantation technique may provide a less invasive treatment option for advanced keratoconus than current surgical approaches, that additionally does not rely on the limited availability of human donor corneal tissue.

Detailed Description

This is a Phase I, open-label, non-randomized, non-controlled ongoing clinical case series in two participating centers in Indian and Iranian hospitals, to evaluate the safety and feasibility of minimally-invasive surgery of advanced keratoconus using a bioengineered corneal stromal substitute on a compassionate basis to alleviate blindness and low vision, due to the severely limited availability of human corneal donor tissue at these centers relative to the medical need. Patients fulfilling inclusion criteria are recruited consecutively and implanted intra-stromally with the bioengineered substitute, as a less invasive surgery than full-thickness or anterior lamellar corneal transplantation. In the first phase of the study, a total of 20 patients were recruited and safety and efficacy outcomes were evaluated in those having a minimum of 12 months of postoperative follow-up. In the second phase of the study (currently ongoing), up to 40 patients are being recruited, with one-year postoperative outcomes of all included patients to be evaluated as the final study endpoint. Primary safety and efficacy outcomes will be evaluated.

6. Conditions and Keywords

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

Keratoconus

Keywords

corneal blindness, keratoconus, bioengineered cornea, intrastromal implantation, femtosecond laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bioengineered corneal substitute

Arm Type

Experimental

Arm Description

A cell-free, sterilized bioengineered corneal substitute made from medical grade collagen

Intervention Type

Device

Intervention Name(s)

LinkCor Bioengineered Corneal Implant

Intervention Description

Intrastromal implantation of a bioengineered corneal equivalent device

Primary Outcome Measure Information:

Title

Safety outcome measure

Description

Time Frame

6 months

Title

Corneal curvature measured by keratometry (efficacy measure)

Description

Time Frame

6 months

Title

Central corneal thickness measured by topography techniques (efficacy measure)

Description

Time Frame

6 months

Title

Visual acuity (efficacy measure)

Description

Vision improvement equivalent of minimum one line in Snellen chart in uncorrected distance visual acuity (UDVA) or corrected distance visual acuity (CDVA).

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Advanced keratoconus (according to Amsler-Krumeich classification) No corneal scar Male or female aged ≥ 18 years, no upper age limit Subjects indicated for a first corneal stromal transplantation (treatment naïve) Corneal thickness (including epithelium) at least 300µm centrally, as measured by OCT. Patients who gave their written signed and dated informed consent for participation Exclusion Criteria: Prior corneal surgery (e.g., refractive surgery, cataract, collagen cross-linking, endothelial keratoplasty, etc.) Dry eye / tear film pathology Active ocular infection Glaucoma / ocular hypertension Active corneal ulceration Acute or chronic disease or illness that would increase the operation risk or confound the outcomes of the study (immune- compromised, connective tissue disease, clinically significant atopic disease, etc.) Any other medical condition that in the judgment of the clinical investigator or corneal surgeon is not compatible with the study procedures General history judged by the investigator to be incompatible with the study (e.g., life-threatening patient condition, other condition where postoperative follow-up may be difficult). known diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing) Inability of patient to understand the study procedures and thus inability to give informed consent. Participation in another clinical study within the last 3 months Already included once in this study (can only be included for one treated eye).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mehrdad Rafat, PhD

Phone

+46734613166

mrafat@linkocare.com

First Name & Middle Initial & Last Name or Official Title & Degree

Neil Lagali, PhD

Phone

+46 700 850 953

neil.lagali@liu.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Namrata Sharma, MD

Organizational Affiliation

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mahmoud Jabbarvand Behrouz, MD

Organizational Affiliation

University of Tehran, Farabi Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

All India Institute of Medical Sciences, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS,

City

New Delhi

ZIP/Postal Code

110029

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Namrata Sharma, MD, DNB

Phone

+91-011-26593144

namrata.sharma@gmail.com

Facility Name

Farabi Eye Hospital, Tehran University of Medical Sciences

City

Tehran

ZIP/Postal Code

13366

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahmoud Jabbarvand Behrouz, MD

Phone

+989121014161

ma.jabarvand@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35953672

Citation

Rafat M, Jabbarvand M, Sharma N, Xeroudaki M, Tabe S, Omrani R, Thangavelu M, Mukwaya A, Fagerholm P, Lennikov A, Askarizadeh F, Lagali N. Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts. Nat Biotechnol. 2023 Jan;41(1):70-81. doi: 10.1038/s41587-022-01408-w. Epub 2022 Aug 11.

Results Reference

result

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Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus

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