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

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Brief Title

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

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.

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.
    


Study Type

Interventional


Primary Outcome

Safety outcome measure


Condition

Keratoconus

Intervention

LinkCor Bioengineered Corneal Implant

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

November 2016

Completion Date

July 31, 2023

Primary Completion Date

December 31, 2022

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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Namrata Sharma, MD, +46734613166, [email protected]

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT04653922

Organization ID

CMG-PRT-001


Responsible Party

Sponsor

Study Sponsor

LinkoCare Life Sciences AB


Study Sponsor

Namrata Sharma, MD, Principal Investigator, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi


Verification Date

April 2022