Corneal Disease, Corneal Injuries, Corneal Opacity
Conditions
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
Detailed description
The objective of this clinical study is to prove the safety and effectiveness 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. Ten 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, 1, 2, 3, 6, 9 & 12 months post implantation 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 12 months follow up period.
Interventions
DEVICECorNeat KPro
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
Sponsors
CorNeat Vision Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Vulnerable populations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE) | Throughout the 12 months follow up period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint - Improvement in BCDVA | Throughout the 12-months post operation | Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline |
Countries
Canada, France, Israel, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CorNeat KPro Intraocular implantation of the CorNeat KPro
CorNeat KPro: 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | CorNeat KPro |
|---|---|
| Age, Continuous | 64.6 Years |
| Ocular imaging AC depth | 3 Participants |
| Ocular imaging AC Morphology | 6 Participants |
| Ocular imaging Angle Morphology | 7 Participants |
| Ocular imaging Location and position of IOL | 5 Participants |
| Ocular imaging Pachymetry | 7 Participants |
| Pain assessment Mild pain (grades 3-4) | 1 participants |
| Pain assessment Moderate pain (grades 5-7) | 1 participants |
| Pain assessment No or minimal pain (grades 0-2) | 8 participants |
| Pain assessment Severe pain (grades 8-10) | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment Canada | 5 participants |
| Region of Enrollment France | 2 participants |
| Region of Enrollment Israel | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
| Slit lamp examinations AC deep | 8 participants |
| Slit lamp examinations AC medium | 1 participants |
| Slit lamp examinations Anirdia iris | 1 participants |
| Slit lamp examinations Mild cornea edema | 1 participants |
| Slit lamp examinations Moderate cornea edema | 5 participants |
| Slit lamp examinations Morcher, iris prosthetic | 1 participants |
| Slit lamp examinations No cells present | 5 participants |
| Slit lamp examinations No Fibrin present | 7 participants |
| Slit lamp examinations No flare | 5 participants |
| Slit lamp examinations Normal conjunctiva | 10 participants |
| Slit lamp examinations Normal iris | 5 participants |
| Slit lamp examinations Normal Lids/Lashes/Lacrimal | 5 participants |
| Slit lamp examinations Normal macula | 1 participants |
| Slit lamp examinations Normal pupil | 7 participants |
| Slit lamp examinations Normal retinal periphery | 2 participants |
| Slit lamp examinations Normal retinal vessels | 2 participants |
| Slit lamp examinations Normal vitreous body | 4 participants |
| Slit lamp examinations Pale optic nerve | 1 participants |
| Slit lamp examinations Ptosis Lids/Lashes/Lacrimal | 1 participants |
| Slit lamp examinations Severe cornea edema | 4 participants |
| Slit lamp examinations Tarsorrhaphy Lids/Lashes/Lacrimal | 2 participants |
| Slit lamp examinations Trichiasis Lids/Lashes/Lacrimal | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 7 / 10 |
Outcome results
Primary
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
Time frame: Throughout the 12 months follow up period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorNeat KPro | Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE) | 7 Participants |
Secondary
Secondary Effectiveness Endpoint - Improvement in BCDVA
Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
Time frame: Throughout the 12-months post operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CorNeat KPro | Secondary Effectiveness Endpoint - Improvement in BCDVA | 8 Participants |