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

Primary Purpose

Corneal Disease, Corneal Opacity, Corneal Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CorNeat KPro
Sponsored by
CorNeat Vision Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Disease

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female aged ≥ 21 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 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 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; 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 or severely scarred conjunctiva in the target eye End stage glaucoma or evidence of current uncontrolled glaucoma History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis) Active inflammation of the conjunctiva in one or both eyes 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 Ocular ischemic syndrome Signs of current infection, including fever and current treatment with antibiotics Severe generalized disease that results in a life expectancy shorter than two years 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 Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure 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 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) Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space

Sites / Locations

  • University of British Columbia
  • UHN - University Health Network
  • CHU de Montpellier
  • Hopital Fondation Adolphe de Rothschild
  • Rabin Medical Center - Beilinson
  • Amsterdam UMC - Location AMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CorNeat KPro

Arm Description

Intraocular implantation of the CorNeat KPro

Outcomes

Primary Outcome Measures

Safety Assessment
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation

Secondary Outcome Measures

Retention rate
The number of retained devices at the end of 24- months follow up period will be calculated
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline
Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after

Full Information

First Posted
January 12, 2023
Last Updated
September 3, 2023
Sponsor
CorNeat Vision Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05694247
Brief Title
Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CorNeat Vision Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Disease, Corneal Opacity, Corneal Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CorNeat KPro
Arm Type
Experimental
Arm Description
Intraocular implantation of the CorNeat KPro
Intervention Type
Device
Intervention Name(s)
CorNeat KPro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Assessment
Description
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation
Time Frame
Throughout 24 months post-op
Secondary Outcome Measure Information:
Title
Retention rate
Description
The number of retained devices at the end of 24- months follow up period will be calculated
Time Frame
24 months post-op
Title
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline
Description
Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after
Time Frame
Throughout 24 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged ≥ 21 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 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 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; 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 or severely scarred conjunctiva in the target eye End stage glaucoma or evidence of current uncontrolled glaucoma History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis) Active inflammation of the conjunctiva in one or both eyes 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 Ocular ischemic syndrome Signs of current infection, including fever and current treatment with antibiotics Severe generalized disease that results in a life expectancy shorter than two years 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 Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure 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 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) Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ido Klein, B.Sc, MBA
Phone
+972549350507
Email
ido@corneat.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luba Vitkin Katz, B.Sc, MBA
Phone
972526612736
Email
luba@corneat.com
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Iovieno, M.D
Phone
604 875 4555
First Name & Middle Initial & Last Name & Degree
Alfonso Iovieno, MD, PhD
Facility Name
UHN - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Hung, BAT Ind.Des., OA
Phone
(416) 603-5800
Ext
3106
Email
judy.hung@uhn.ca
First Name & Middle Initial & Last Name & Degree
Clara Chan, MD
First Name & Middle Initial & Last Name & Degree
David Rootman, MD, FRCS(C)
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Croudy
Phone
04 67 33 79 62
Email
h-CROWDY@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Vincent Daien, M.D
Facility Name
Hopital Fondation Adolphe de Rothschild
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Vachey
Phone
0148036433
Email
pvachey@for.paris
First Name & Middle Initial & Last Name & Degree
Eric Gabizon, M.D
Facility Name
Rabin Medical Center - Beilinson
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilla German
Phone
9723-9376100
Email
eyeclinic@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Irit Bahar, MD PhD
First Name & Middle Initial & Last Name & Degree
Eitan Livni, MD
Facility Name
Amsterdam UMC - Location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Wezel
Phone
+31205668618
Email
m.wezel@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Ruth Lapid-Gortzak, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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