Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

Corneal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694247
• Other study ID #: DMS-35932
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: CorNeat Vision Ltd.
• Contact: Ido Klein, B.Sc, MBA
• Phone: +972549350507
• Email: ido[@]corneat.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This clinical trial will assess the clinical safety and performance 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.

40 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, 2 weeks, 1, 2, 3, 4, 5, 6,8, 10,12,15,18,21 and 24 months post-surgery 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 24 months follow up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• CorNeat KPro
The optical component of the CorNeat KPro will be implanted into a circular disc of the cornea (as performed in standard penetrating keratoplasty surgery) and the skirt component will be embedded under a 360º conjunctival flap.

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

Sponsors (1)

Lead Sponsor	Collaborator
CorNeat Vision Ltd.

Countries where clinical trial is conducted

Canada,  France,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment	The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation	Throughout 24 months post-op
Secondary	Retention rate	The number of retained devices at the end of 24- months follow up period will be calculated	24 months post-op
Secondary	Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline	Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after	Throughout 24 months post-op