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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04653922
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
LinkoCare Life Sciences AB

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.

Condition or disease Intervention/treatment Phase
Keratoconus Device: LinkCor Bioengineered Corneal Implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bioengineered corneal substitute
A cell-free, sterilized bioengineered corneal substitute made from medical grade collagen
Device: LinkCor Bioengineered Corneal Implant
Intrastromal implantation of a bioengineered corneal equivalent device




Primary Outcome Measures :
  1. Safety outcome measure [ Time Frame: 6 months ]
    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.

  2. Corneal curvature measured by keratometry (efficacy measure) [ Time Frame: 6 months ]
    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.

  3. Central corneal thickness measured by topography techniques (efficacy measure) [ Time Frame: 6 months ]
    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.

  4. Visual acuity (efficacy measure) [ Time Frame: 6 months ]
    Vision improvement equivalent of minimum one line in Snellen chart in uncorrected distance visual acuity (UDVA) or corrected distance visual acuity (CDVA).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653922


Contacts
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Contact: Mehrdad Rafat, PhD +46734613166 mrafat@linkocare.com
Contact: Neil Lagali, PhD +46 700 850 953 neil.lagali@liu.se

Locations
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India
All India Institute of Medical Sciences, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Recruiting
New Delhi, India, 110029
Contact: Namrata Sharma, MD, DNB    +91-011-26593144    namrata.sharma@gmail.com   
Iran, Islamic Republic of
Farabi Eye Hospital, Tehran University of Medical Sciences Recruiting
Tehran, Iran, Islamic Republic of, 13366
Contact: Mahmoud Jabbarvand Behrouz, MD    +989121014161    ma.jabarvand@gmail.com   
Sponsors and Collaborators
LinkoCare Life Sciences AB
Investigators
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Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LinkoCare Life Sciences AB
ClinicalTrials.gov Identifier: NCT04653922    
Other Study ID Numbers: CMG-PRT-001
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LinkoCare Life Sciences AB:
corneal blindness
keratoconus
bioengineered cornea
intrastromal implantation
femtosecond laser
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases