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

NCT04485858 | Terminated Results DMC FDA Device

• 1 other identifier: DMS-15012
• Study Type: interventional
• Target: 10
• Locations: 5 countries
• Sites: 8

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

Conditions

Corneal Disease; Corneal Opacity; Corneal Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Effectiveness Endpoint - Improvement in BCDVA

  Throughout the 12-months post operation

Study Arms (1)

CorNeat KPro

EXPERIMENTAL

Intraocular implantation of the CorNeat KPro

Device: CorNeat KPro

Interventions

CorNeat KPro DEVICE

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

CorNeat KPro

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• CorNeat Vision Ltd.: lead

Study Sites (8)

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 3N9, Canada

Location

UHN - University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Hopital Fondation Adolphe de Rothschild

Paris, France

Location

Rabin Medical Center - Beilinson

Petah Tikva, 4941492, Israel

Location

Amsterdam UMC - Location AMC

Amsterdam, Netherlands

Location

Maastricht UMC+

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Corneal Diseases; Corneal Opacity; Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Results Point of Contact

• Title: Clinical Research Associate
• Organization: CorNeat Vision

talia@corneat.com

0586753739

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 24, 2020
• Study Start: January 3, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Locations

US (1); NL (2); CA (2); FR (2); IL (1)