Clinical trial NCT04485858: 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
Overall status: TERMINATED
Phase: NA
Conditions: Corneal Disease
Corneal Opacity
Corneal Injuries
Lead sponsor: CorNeat Vision Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
timeFrame: Throughout the 12 months follow up period
Secondary outcomes:
measure: Secondary Effectiveness Endpoint - Improvement in BCDVA
timeFrame: Throughout the 12-months post operation
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: UHN - University Health Network
state: Ontario
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Hopital Fondation Adolphe de Rothschild
city: Petah tikva
country: Israel
facility: Rabin Medical Center - Beilinson
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Location AMC
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
Study officials:
References: