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

NCT04653922 | Completed DMC

• 1 other identifier: CMG-PRT-001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

Keratoconus

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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).

  6 months

Study Arms (1)

Bioengineered corneal substitute

EXPERIMENTAL

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

Device: LinkCor Bioengineered Corneal Implant

Interventions

LinkCor Bioengineered Corneal Implant DEVICE

Intrastromal implantation of a bioengineered corneal equivalent device

Bioengineered corneal substitute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• LinkoCare Life Sciences AB: lead

Study Sites (2)

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

New Delhi, 110029, India

Location

Farabi Eye Hospital, Tehran University of Medical Sciences

Tehran, 13366, Iran

Location

Related Publications (1)

• 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.

  PMID: 35953672 RESULT

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Namrata Sharma, MD

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

  PRINCIPAL INVESTIGATOR

• Mahmoud Jabbarvand Behrouz, MD

  University of Tehran, Farabi Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 4, 2020
• Study Start: November 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2023
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1); IN (1)