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Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

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ClinicalTrials.gov Identifier: NCT05694247
Recruitment Status : Recruiting
First Posted : January 23, 2023
Last Update Posted : March 1, 2024
Sponsor:
Information provided by (Responsible Party):
CorNeat Vision Ltd.

Study Description
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Brief Summary:
A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

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

Detailed Description:

This clinical trial will assess the clinical safety and performance 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.

40 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, 2 weeks, 1, 2, 3, 4, 5, 6,8, 10,12,15,18,21 and 24 months post-surgery 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 24 months follow up period.

Study Design
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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: A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CorNeat KPro
Intraocular implantation of the CorNeat KPro
 Device: CorNeat KPro
The optical component of the CorNeat KPro will be implanted into a circular disc of the cornea (as performed in standard penetrating keratoplasty surgery) and the skirt component will be embedded under a 360º conjunctival flap.


Outcome Measures
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Primary Outcome Measures :
  1. Safety Assessment [ Time Frame: Throughout 24 months post-op ]
    The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation


Secondary Outcome Measures :
  1. Retention rate [ Time Frame: 24 months post-op ]
    The number of retained devices at the end of 24- months follow up period will be calculated

  2. Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline [ Time Frame: Throughout 24 months post-op ]
    Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged ≥ 21 and ≤ 80 years on the day of screening
  2. Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
  3. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye
  4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation.
  5. 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;
  6. Adequate tear film and lid function
  7. Perception of light in all quadrants
  8. 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:

  1. Reasonable chance of success with traditional keratoplasty
  2. Current retinal detachment
  3. Connective tissue diseases or severely scarred conjunctiva in the target eye
  4. End stage glaucoma or evidence of current uncontrolled glaucoma
  5. History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis)
  6. Active inflammation of the conjunctiva in one or both eyes
  7. History of ocular or periocular malignancy
  8. History of extensive keloid formation
  9. Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
  10. Ocular ischemic syndrome
  11. Signs of current infection, including fever and current treatment with antibiotics
  12. Severe generalized disease that results in a life expectancy shorter than two years
  13. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
  14. 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
  15. Currently pregnant or breastfeeding
  16. 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
  17. Intraoperative complication that would preclude implantation of the study device
  18. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes
  19. Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure
  20. Vulnerable populations - minors, pregnant women, prisoners, sponsor or study institution employees, military persons, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized patients and refugees
  21. Subjects with corneal disorders located outside the central 7 mm, such as Mooren ulcer, peripheral ulcerative keratitis, and necrotizing herpetic keratitis (if located outside the central 7 mm of the cornea)
  22. Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space
Contacts and Locations
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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): NCT05694247


Contacts
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Contact: Ido Klein, B.Sc, MBA +972549350507 ido@corneat.com
Contact: Gilad Litvin, MD +972 50-351-4057 gilad@corneat.com

Locations
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Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 3N9
Contact: Alfonso Iovieno, M.D    604 875 4555      
Principal Investigator: Alfonso Iovieno, MD, PhD         
Canada, Ontario
UHN - University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Judy Hung, BAT Ind.Des., OA    (416) 603-5800 ext 3106    judy.hung@uhn.ca   
Principal Investigator: Clara Chan, MD         
Sub-Investigator: David Rootman, MD, FRCS(C)         
France
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Hannah Croudy    04 67 33 79 62    h-CROWDY@chu-montpellier.fr   
Principal Investigator: Vincent Daien, M.D         
Hopital Fondation Adolphe de Rothschild Recruiting
Paris, France
Contact: Patrick Vachey    0148036433    pvachey@for.paris   
Principal Investigator: Eric Gabizon, M.D         
Israel
Rabin Medical Center - Beilinson Recruiting
Petah tikva, Israel, 4941492
Contact: Hilla German    9723-9376100    eyeclinic@clalit.org.il   
Principal Investigator: Irit Bahar, MD PhD         
Sub-Investigator: Eitan Livni, MD         
Netherlands
Amsterdam UMC - Location AMC Not yet recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Monique Wezel    +31205668618    m.wezel@amsterdamumc.nl   
Principal Investigator: Ruth Lapid-Gortzak, MD PhD         
Sponsors and Collaborators
CorNeat Vision Ltd.
More Information
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Responsible Party: CorNeat Vision Ltd.
ClinicalTrials.gov Identifier: NCT05694247    
Other Study ID Numbers: DMS-35932
First Posted: January 23, 2023    Key Record Dates
Last Update Posted: March 1, 2024
Last Verified: February 2024
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
Product Manufactured in and Exported from the U.S.: 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
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries