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

Stopped early · Not applicable

Conditions studied: Corneal Disease, Corneal Opacity, Corneal Injuries

In brief

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

Key facts

Study ID

NCT04485858

Run by

CorNeat Vision Ltd.

People needed

10

Starts

2021-01-03

Expected to finish

2023-06-01

Last updated by the study team

2024-09-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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