The objective of this clinical study is to prove the safety of the CorNeat KPro.
ID
Source
Brief title
Condition
- Anterior eye structural change, deposit and degeneration
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint is 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 24 months. The
frequency should be less than SOC (as detailed in the Investigator*s Brochure).
Secondary outcome
Effectiveness Endpoints:
(i) Primary Endpoint: Retention of implant;
(ii) Secondary Endpoint: Improved visual acuity
Background summary
Corneal pathology is a leading cause of blindness worldwide with 20-30 million
patients in need of a remedy and around 2 million new cases/year. The
epidemiology of corneal blindness is complex and encompasses injury and a wide
variety of infectious, genetic, and inflammatory eye diseases, which cause
corneal scarring or opacity and lead to functional blindness.
Current solutions for corneal blindness and disease include penetrating
keratoplasty (PKP; corneal transplantation), lamellar keratoplasty (DMEK,
DALK), and rarely keratoprosthesis (KPro; artificial cornea implantation).
Together, keratoplasty and to a much lesser extent KPros address 5%-10% of
global cases due to lack of tissue availability, low graft survival rates and
the fact that some corneal blindness indications are not suitable for
keratoplasty. Thus, there is an ever-growing number of patients for whom there
is no suitable solution.
An artificial solution would solve many shortcomings of the current available
treatments and therefore alleviate the suffering of scores of affected
individuals, predominantly in the developing world.
So far, attempts at creating scalable KPros have failed. Whereas previous KPros
have integrated an artificial lens into a biological substrate that was then
implanted into the eye, the CorNeat KPro is entirely synthetic, comprised of a
microporous skirt that leverages the subconjunctival space for integration.
Study objective
The objective of this clinical study is to prove the safety of the CorNeat
KPro.
Study design
Prospective, open label, single arm, First-in-human (FIH) clinical study to
assess safety and efficacy of the CorNeat KPro for the treatment of corneal
blindness. Subjects will be followed up for 24 mon
Intervention
The CorNeat KPro will be implanted into the subject*s eye with the optic
component snapping into the patient*s trephined cornea then sutured to the eye
wall using 3 non-degradable sutures and the skirt component will be placed
under the conjunctiva that will be repositioned to cover the skirt.
Study burden and risks
Taking part in this study poses some known risks such as glaucoma, Retro
Prosthetic Membrane (RPM), endophthalmitis, inflammatory reaction around the
implant, foreign body sensation, stromal melting, poor post-operative visual
quality, intra ocular bleeding, retinal detachment, droopy eyelid.
There is some risk related to study procedures such as side effects of the
dilation and anesthetic drops and general anesthesia risks like mouth or throat
pain, injury to mouth or teeth, allergic reaction to anesthetic etc.
The CorNeat KPro can provide visual rehabilitation for severely diseased
corneas at high risk for failure with traditional corneal transplantation.
The CorNeat KPro may reduce the major risks that Keratoprosthesis surgery holds
such as corneal melt, elevation of intraocular pressure and endophthalmitis.
Moreover, implantation of CorNeat KPro may provide the patients with improved
visual quality as compared to current solutions.
Hasheizaf st. 4
Raanana 4366411
NL
Hasheizaf st. 4
Raanana 4366411
NL
Listed location countries
Age
Inclusion criteria
1. Male or female aged >= 18 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. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a
reasonable option or following a verifiable history of prior failed corneal
transplantation.
4. Indications that fall under poor candidate for keratoplasty include but are
not limited to: herpetic keratitis, vascularized corneal scar, Ocular
Cicatricial Pemphigoid, chemical or thermal burn, Steven Johnson Syndrome, and
limbal stem cell deficiency;
5. Adequate tear film and lid function
6. Perception of light in all quadrants
7. 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. 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, specifically acrylate
10. Signs of current infection, including fever and current treatment with
antibiotics
11. Severe generalized disease that results in a life expectancy shorter than a
year
12. Any clinical evidence that the investigator feels would place the subject
at increased risk with the placement of the device
13. Currently pregnant or breastfeeding
14. 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
15. Intraoperative complication that would preclude implantation of the study
device.
16. Vulnerable populations.
17. Active orbital, scleral or corneal inflammation
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. Ocular ischemic syndrome
21. Severely scarred conjunctiva
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04485858 |
| CCMO | NL75316.000.21 |