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

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

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

Study Overview

• Status: Terminated
• Conditions: Corneal Opacity; Corneal Disease; Corneal Injuries
• Intervention / Treatment: Device: CorNeat KPro

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerry Tal, B.Sc, MBA; Phone Number: +972 52-356-2826; Email: gerry@corneat.com
• Study Contact Backup: Name: Ido Klein, B.Sc, MBA; Phone Number: +972549350507; Email: ido@corneat.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 3N9
      • University of British Columbia
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • UHN - University Health Network
• France
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Paris, France
    • Hôpital Fondation Adolphe de Rothschild
• Israel
  • Petah tikva, Israel, 4941492
    • Rabin Medical Center - Beilinson
• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC - Location AMC
  • Maastricht, Netherlands, 6229 HX
    • Maastricht UMC+
• United States
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint as determined by the frequency and severity of all unanticipated adverse device-related events (UADE)	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	Throughout the 12 months follow up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary effectiveness Endpoint - Device retention rate	Incidence of device retention as determined by slit-lamp biomicroscopy at last follow up visit	12-months
Secondary effectiveness Endpoint - Improvement in BCDVA	Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline	12-months

Collaborators and Investigators

• Sponsor: CorNeat Vision Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Sensation Disorders; Vision Disorders; Facial Injuries; Eye Injuries; Corneal Opacity; Blindness; Corneal Diseases; Corneal Injuries
• Other Study ID Numbers: KPro-CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes