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

Corneal Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04485858
• Other study ID #: KPro-CIP-001
• Status: Terminated
• Phase: N/A
• Start date: January 3, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: CorNeat Vision Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blindness
• Corneal Disease
• Corneal Diseases
• Corneal Injuries
• Corneal Opacity

Intervention

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

Locations

Country	Name	City	State
Canada	UHN - University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
France	CHU de Montpellier	Montpellier
France	Hopital Fondation Adolphe de Rothschild	Paris
Israel	Rabin Medical Center - Beilinson	Petah tikva
Netherlands	Amsterdam UMC - Location AMC	Amsterdam
Netherlands	Maastricht UMC+	Maastricht
United States	Cincinnati Eye Institute	Edgewood	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
CorNeat Vision Ltd.

Countries where clinical trial is conducted

United States,  Canada,  France,  Israel,  Netherlands, 

Outcome

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