Clinical trial NCT05694247: Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Corneal Disease
Corneal Opacity
Corneal Injuries
Lead sponsor: CorNeat Vision Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed 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.

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

Primary outcomes:
measure: Safety Assessment
timeFrame: Throughout 24 months post-op
Secondary outcomes:
measure: Retention rate
timeFrame: 24 months post-op
measure: Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline
timeFrame: Throughout 24 months post-op
Other outcomes:
Locations:
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
Study officials:
References: