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

Primary Purpose

Corneal Disease, Corneal Opacity, Corneal Injuries

Status
Terminated
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

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

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

Sites / Locations

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

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 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

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2020
Last Updated
September 3, 2023
Sponsor
CorNeat Vision Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04485858
Brief Title
First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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
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.

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
10 (Actual)

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
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 Measure Information:
Title
Safety Endpoint as determined by the frequency and severity of all unanticipated adverse device-related events (UADE)
Description
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
Time Frame
Throughout the 12 months follow up period
Secondary Outcome Measure Information:
Title
Primary effectiveness Endpoint - Device retention rate
Description
Incidence of device retention as determined by slit-lamp biomicroscopy at last follow up visit
Time Frame
12-months
Title
Secondary effectiveness Endpoint - Improvement in BCDVA
Description
Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cincinnati Eye Institute
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Name
UHN - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Fondation Adolphe de Rothschild
City
Paris
Country
France
Facility Name
Rabin Medical Center - Beilinson
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Amsterdam UMC - Location AMC
City
Amsterdam
Country
Netherlands
Facility Name
Maastricht UMC+
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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