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First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness

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: NCT04485858
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
CorNeat Vision Ltd.

Brief Summary:
Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness

Condition or disease Intervention/treatment Phase
Corneal Disease Corneal Opacity Corneal Injuries Device: CorNeat KPro Not Applicable

Detailed Description:

The objective of this clinical study is to prove the safety and effectiveness of the CorNeat Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment of corneal blindness in subjects who are not candidates for traditional corneal transplant.

Ten subjects who are willing to take part in the study will undergo screening examinations to verify their eligibility.

The CorNeat KPro will be implanted unilaterally in eligible subjects. Follow up procedures will be performed at 1 day, 1 week, 1, 2, 3, 6, 9 & 12 months post implantation and will include clinical assessment of the implanted eye using slit-lamp biomicroscopy, intra ocular pressure measurement and ocular imaging. Additionally, subjects' visual acuity will be assessed and recorded throughout the 12 months follow up period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CorNeat KPro
Intraocular implantation of the CorNeat KPro
Device: CorNeat KPro
CorNeat KPro will be implanted into the subject's eye where the optic component snaps into the patient's trephined cornea and is sutured to the eye wall using 3 non-degradable sutures and the skirt component is placed under the conjunctiva




Primary Outcome Measures :
  1. Safety Endpoint as determined by the frequency and severity of all unanticipated adverse device-related events (UADE) [ Time Frame: Throughout the 12 months follow up period ]
    The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC


Secondary Outcome Measures :
  1. Primary effectiveness Endpoint - Device retention rate [ Time Frame: 12-months ]
    Incidence of device retention as determined by slit-lamp biomicroscopy at last follow up visit

  2. Secondary effectiveness Endpoint - Improvement in BCDVA [ Time Frame: 12-months ]
    Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged ≥ 18 and ≤ 80 years on the day of screening
  • Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
  • Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation
  • Indications that fall under poor candidate for keratoplasty include but are not limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency
  • Pseudophakia
  • Adequate tear film and lid function
  • Perception of light in all quadrants
  • Female patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study

Exclusion Criteria:

  • Reasonable chance of success with traditional keratoplasty
  • Current retinal detachment
  • Connective tissue diseases
  • End-stage glaucoma
  • History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation
  • History of ocular or periocular malignancy
  • History of extensive keloid formation
  • Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
  • Signs of current infection, including fever and current treatment with antibiotics
  • Severe generalized disease that results in a life expectancy shorter than a year
  • Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
  • Corneal thickness less than 400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be operated
  • Currently pregnant or breastfeeding
  • Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device
  • Intraoperative complication that would preclude implantation of the study device
  • Vulnerable populations

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): NCT04485858


Contacts
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Contact: Gerry Tal, B.Sc, MBA +972 52-356-2826 gerry@corneat.com
Contact: Ido Klein, B.Sc, MBA +972549350507 ido@corneat.com

Sponsors and Collaborators
CorNeat Vision Ltd.
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Responsible Party: CorNeat Vision Ltd.
ClinicalTrials.gov Identifier: NCT04485858    
Other Study ID Numbers: KPro-CIP-001
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blindness
Corneal Injuries
Corneal Diseases
Corneal Opacity
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries