Corneal DiseaseNCT04485858
First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
A study testing CorNeat KPro in people with Corneal Disease and Corneal Opacity, run by CorNeat Vision Ltd. at 8 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Disease, Corneal Opacity, Corneal Injuries
- What is being tested?
- CorNeat KPro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 3 Jan 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Canada2 sites
UHN - University Health Network
Toronto, Ontario, M5T 2S8
University of British Columbia
Vancouver, British Columbia, V5Z 3N9
France2 sites
CHU de Montpellier
Montpellier, 34295
Hopital Fondation Adolphe de Rothschild
Paris
Netherlands2 sites
Amsterdam UMC - Location AMC
Amsterdam
Maastricht UMC+
Maastricht, 6229 HX
About this study
Official title: Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness
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
Read the 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.
- Conditions
- Corneal Disease, Corneal Opacity, Corneal Injuries
- Being tested
- CorNeat KPro
- Medical subject headings
- Corneal Diseases, Corneal Opacity, Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorNeat KProDevice
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
| Study group | Role | What they receive |
|---|---|---|
| CorNeat KPro | Experimental | Intraocular implantation of the CorNeat KPro Receives: Device: CorNeat KPro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout the 12 months follow up period
Secondary outcomes (1)
Secondary Effectiveness Endpoint - Improvement in BCDVA
Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
Measured: Throughout the 12-months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start3 Jan 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorNeat Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485858
- Sponsor's protocol ID
- DMS-15012
- Status last verified
- Sep 2024
- First submitted
- 8 Jul 2020
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness
- ClinicalTrials.gov ID
- NCT04485858
- Acronym / sponsor ID
- DMS-15012
- Conditions
- Corneal Disease, Corneal Opacity, Corneal Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CorNeat Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CorNeat KPro | Experimental | Device: CorNeat KProIntraocular implantation of the CorNeat KPro |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorNeat KProCorNeat 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 | Device | CorNeat KPro |
Primary outcome
Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
Time frame: 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
1 secondary outcome
Secondary Effectiveness Endpoint - Improvement in BCDVA
Time frame: Throughout the 12-months post operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorNeat KPro in people with Corneal Disease and Corneal Opacity, run by CorNeat Vision Ltd. at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, France, Netherlands, United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE) (time frame: Throughout the 12 months follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.