Evaluating a synthetic cornea for treating corneal blindness

A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

This study is testing a new artificial cornea to see if it can help people with corneal blindness who can't have regular cornea transplants regain their vision and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: CorNeat Vision Ltd. (Industry-sponsored)
• Locations: 6 sites (Vancouver, British Columbia and 5 other locations)
• Trial ID: NCT05694247 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and performance of the CorNeat Keratoprosthesis (KPro), a synthetic artificial cornea designed for patients with corneal blindness who are not suitable candidates for traditional corneal transplants. The study will involve 40 subjects who will undergo screening to confirm eligibility and receive the KPro implant unilaterally. Participants will be monitored through a series of follow-up assessments over 24 months, including visual acuity tests and ocular imaging. The goal is to determine the effectiveness of the KPro in restoring vision and improving quality of life for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 80 who are legally blind and have conditions that make them unsuitable for corneal transplants.

Not a fit: Patients who have conditions that do not meet the inclusion criteria or those who are not legally blind may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for restoring vision in patients with corneal blindness who cannot undergo traditional transplant procedures.

How similar studies have performed: While the CorNeat KPro represents a novel approach, similar studies involving synthetic corneas have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

1. Male or female aged ≥ 21 and ≤ 80 years on the day of screening
2. Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
3. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye
4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation.
5. 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;
6. Adequate tear film and lid function
7. Perception of light in all quadrants
8. 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:

1. Reasonable chance of success with traditional keratoplasty
2. Current retinal detachment
3. Connective tissue diseases or severely scarred conjunctiva in the target eye
4. End stage glaucoma or evidence of current uncontrolled glaucoma
5. History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis)
6. Active inflammation of the conjunctiva in one or both eyes
7. History of ocular or periocular malignancy
8. History of extensive keloid formation
9. Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
10. Ocular ischemic syndrome
11. Signs of current infection, including fever and current treatment with antibiotics
12. Severe generalized disease that results in a life expectancy shorter than two years
13. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
14. 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
15. Currently pregnant or breastfeeding
16. 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
17. Intraoperative complication that would preclude implantation of the study device
18. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes
19. Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure
20. Vulnerable populations - minors, pregnant women, prisoners, sponsor or study institution employees, military persons, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized patients and refugees
21. Subjects with corneal disorders located outside the central 7 mm, such as Mooren ulcer, peripheral ulcerative keratitis, and necrotizing herpetic keratitis (if located outside the central 7 mm of the cornea)
22. Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space

Where this trial is running

Vancouver, British Columbia and 5 other locations

• University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
• UHN - University Health Network — Toronto, Ontario, Canada (Not_yet_recruiting)
• CHU de Montpellier — Montpellier, France (Recruiting)
• Hopital Fondation Adolphe de Rothschild — Paris, France (Recruiting)
• Rabin Medical Center - Beilinson — Petah tikva, Israel (Recruiting)
• Amsterdam UMC - Location AMC — Amsterdam, Netherlands (Not_yet_recruiting)

Study contacts

• Study coordinator: Ido Klein, B.Sc, MBA

Conditions Corneal Disease; Corneal Opacity; Corneal Injuries