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

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ClinicalTrials.gov Identifier: NCT04485858
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : October 22, 2021
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 : 40 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
Actual Study Start Date : January 3, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

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

Locations
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United States, California
UCLA - The Jules Stein Eye Institute Not yet recruiting
Los Angeles, California, United States, 90095-7003
Contact: Ellen Pascual       pascual@jsei.ucla.edu   
Principal Investigator: Anthony J Aldave, MD         
United States, Kentucky
Cincinnati Eye Institute Not yet recruiting
Edgewood, Kentucky, United States, 41017
Contact: Katie Hogeback    859-331-9000 ext 4517    khogeback@cvphealth.com   
Principal Investigator: Edward Holland, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 3N9
Contact: Aleksandra Kuzmanovic    604 875 4555    akuzmanovic@shaw.ca   
Principal Investigator: Alfonso Iovieno, MD, PhD         
Sub-Investigator: Sonia Yeung, MD         
Canada, Ontario
UHN - University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Olivera Sutakovic, MD    (416) 603-5800 ext 5125    olivera.sutakovic@uhn.ca   
Principal Investigator: David Rootman, MD, FRCS(C)         
Sub-Investigator: Clara Chan, MD         
France
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Anne-Sophie AUBERTIE    04.67.33.51.91    externe@chu-montpellier.fr   
Principal Investigator: Vincent Daien, MD         
Hopital Fondation Adolphe de Rothschild Recruiting
Paris, France
Contact: Patrick Vachey    0148036433    pvachey@for.paris   
Principal Investigator: Eric Gabison, MD         
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         
Sub-Investigator: Yoav Nahum, MD         
Netherlands
Amsterdam UMC - Location AMC Recruiting
Amsterdam, Netherlands
Contact: Monique Wezel    +31 20 5668618    m.wezel@amsterdamumc.nl   
Principal Investigator: Ruth Lapid-Gortzak, MD PhD         
Sub-Investigator: Ivanka van der Meulen, MD         
Maastricht UMC+ Not yet recruiting
Maastricht, Netherlands, 6229 HX
Contact: Frank van den Biggelaar, PhD         
Principal Investigator: Rudy Nuijts, MD PhD         
Sub-Investigator: Mor Dickman, MD         
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: October 22, 2021
Last Verified: October 2021
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
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