Glaucoma EyeNCT04037917
First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute
A study testing CorNeat EverPatch in people with Glaucoma Eye and Tissue Breakdown, run by CorNeat Vision Ltd. at 6 sites in 3 countries.
Trial summary
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma Eye, Tissue Breakdown
- What is being tested?
- CorNeat EverPatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 11 Dec 2020to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 screening day
- Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.
- Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
- Adequate tear film and lid function
- Visual acuity of light perception or better
- Female patients of childbearing age must agree to use a method of contraception and have negative pregnancy test at screening. An effective method of contraception must be used throughout the study.
Who cannot join
- Current retinal detachment
- Active ocular or orbital infection
- 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 anesthetics, mydriatics, or component of the device
Show all 15Show fewer
- 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
- 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.
- Any traumatic perforation
- Tissue gaps/weaknesses, resulting either from traumatic, disease-related or iatrogenic damage
- Loss of scleral integrity where use of tissue or substitutes is indicated.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Kenya3 sites
Kwale eye hospital
Mombasa
Kenyatta National Hospital
Nairobi
Lions SightFirst Hospital
Nairobi
Canada2 sites
Prism Eye Institute
Oakville, Ontario, L6H OJ8
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: The CorNeat EverPatch - a First-In-Man Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts
Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts
The study will consist 10 subjects requiring concealment of a glaucoma shunt or other ophthalmic implant. Eligible subjects who signs an ICF will be enrolled to the study. Subjects will be implanted with the Corneart EverPatch as part of a glaucoma shunt surgery or during a corrective surgery to repair a breached conjunctiva over an implanted device. Subjects will be monitored for a period of 12 months post-op during which follow up visits will occur at 1 week, 1, 2, 3, 6, 9 \& 12 months following surgery including clinical examination of the operated eye using slit-lamp biomicroscopy and imaging using OCT or UBM (will be performed only at the 6 \& 12 months follow up visits).
Read the detailed description
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts
Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts
Study endpoints:
Primary Safety Endpoint:
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation and follow-up for up to 12 months will be 10% or less.
Effectiveness Endpoints:
Primary: Conjunctival integrity at the implantation site will be 90% or more. Secondary: Stability in patch dimensions, less than 10% change (length, projected width and thickness) measured by OCT after 1-week and follow-up for up to 12 months post-implantation in 90% of the implanted patients.
Intended uses: The CorNeat EverPatch intended use is concealment of artificial ophthalmic implants and glaucoma tube shunts.
The clinical investigation of the CorNeat EverPatch device is essential to validate its safety and efficacy in its target implantation site and to substantiate regulatory clearance. Clinical investigation of a medical device must be in compliance with Good Clinical Practice as set forth in ISO 14155, which addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects for the purpose of assessing the safety and performance of medical devices for regulatory purposes, as well as applicable local laws and regulations.
Study Population: 10 subjects requiring concealment of artificial ophthalmic implants and glaucoma tube shunts. Unilateral and bi-lateral. The device can be implanted in patients' right or left eye (selection according to Principle Investigator's discretion).
Study Duration: Subjects will be followed-up for 12 months from device implantation date.
Visit Schedule:
- Screening: Day 0-7, Subjects will sign an Informed Consent Form (ICF) on screening visit and baseline assessments for clinical condition, concomitant medication and medical history data will be performed.
- Implantation: Implantation day will be recorded as day 0; enrollment day.
- Follow up visits at 1 week, 1, 2, 3, 6, 9 \& 12-month post-op (total of 7 follow up visits).
At each follow up visit, subjects will be evaluated for: (i) conjunctival integrity; (ii) device dimensions, (iii) clinical evaluation; (iv) device retention and (v) any clinically necessary interim safety exam per PI decision. Additionally, at 6 \& 12 months post-op, subjects will undergo an imaging evaluation of the device's dimensions (either by UBM or OCT).
Safety Assessment: A record of UADE as well as incidence and nature of Serious Adverse Events (SAE) will be recorded. Incidence and nature of Adverse Events (AE) will be collected throughout the study starting from implantation. The following types of events are outside of this category:
(i) Adverse events related to the disease such as glaucoma and not caused by implant concealment (ii) Adverse events related to the primary implant such as tube shunt blockage not related to implant concealment
- Conditions
- Glaucoma Eye, Tissue Breakdown
- Being tested
- CorNeat EverPatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorNeat EverPatchDevice
Covering Ophthalmic Implants
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Tissue Substitute | Experimental | Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants Receives: Device: CorNeat EverPatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-related adverse events
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events
Measured: up to 12 months
Secondary outcomes (2)
Conjunctival integrity
Conjunctival integrity at the implantation should be 90% or more as measured by Slit lamp examination
Measured: up to 12 months
Stability in patch dimensions
Stability in patch dimensions should show less than 10% change (length, projected width and thickness) measured by OCT after 1-week and follow-up for up to 12 months post-implantation in 90% of the implanted patients
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start11 Dec 2020
- Primary completion30 Apr 2023
- Study completion1 Jul 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma EyeStudies 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
- 28 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
- NCT04037917
- Sponsor's protocol ID
- SP-001
- Status last verified
- Apr 2022
- First submitted
- 15 May 2019
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CorNeat EverPatch - a First-In-Man Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts
- ClinicalTrials.gov ID
- NCT04037917
- Acronym / sponsor ID
- SP-001
- Conditions
- Glaucoma Eye, Tissue Breakdown
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CorNeat Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts
Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts
The study will consist 10 subjects requiring concealment of a glaucoma shunt or other ophthalmic implant. Eligible subjects who signs an ICF will be enrolled to the study. Subjects will be implanted with the Corneart EverPatch as part of a glaucoma shunt surgery or during a corrective surgery to repair a breached conjunctiva over an implanted device. Subjects will be monitored for a period of 12 months post-op during which follow up visits will occur at 1 week, 1, 2, 3, 6, 9 \& 12 months following surgery including clinical examination of the operated eye using slit-lamp biomicroscopy and imaging using OCT or UBM (will be performed only at the 6 \& 12 months follow up visits).
Detailed description
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts
Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts
Study endpoints:
Primary Safety Endpoint:
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation and follow-up for up to 12 months will be 10% or less.
Effectiveness Endpoints:
Primary: Conjunctival integrity at the implantation site will be 90% or more. Secondary: Stability in patch dimensions, less than 10% change (length, projected width and thickness) measured by OCT after 1-week and follow-up for up to 12 months post-implantation in 90% of the implanted patients.
Intended uses: The CorNeat EverPatch intended use is concealment of artificial ophthalmic implants and glaucoma tube shunts.
The clinical investigation of the CorNeat EverPatch device is essential to validate its safety and efficacy in its target implantation site and to substantiate regulatory clearance. Clinical investigation of a medical device must be in compliance with Good Clinical Practice as set forth in ISO 14155, which addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects for the purpose of assessing the safety and performance of medical devices for regulatory purposes, as well as applicable local laws and regulations.
Study Population: 10 subjects requiring concealment of artificial ophthalmic implants and glaucoma tube shunts. Unilateral and bi-lateral. The device can be implanted in patients' right or left eye (selection according to Principle Investigator's discretion).
Study Duration: Subjects will be followed-up for 12 months from device implantation date.
Visit Schedule:
- Screening: Day 0-7, Subjects will sign an Informed Consent Form (ICF) on screening visit and baseline assessments for clinical condition, concomitant medication and medical history data will be performed.
- Implantation: Implantation day will be recorded as day 0; enrollment day.
- Follow up visits at 1 week, 1, 2, 3, 6, 9 \& 12-month post-op (total of 7 follow up visits).
At each follow up visit, subjects will be evaluated for: (i) conjunctival integrity; (ii) device dimensions, (iii) clinical evaluation; (iv) device retention and (v) any clinically necessary interim safety exam per PI decision. Additionally, at 6 \& 12 months post-op, subjects will undergo an imaging evaluation of the device's dimensions (either by UBM or OCT).
Safety Assessment: A record of UADE as well as incidence and nature of Serious Adverse Events (SAE) will be recorded. Incidence and nature of Adverse Events (AE) will be collected throughout the study starting from implantation. The following types of events are outside of this category:
(i) Adverse events related to the disease such as glaucoma and not caused by implant concealment (ii) Adverse events related to the primary implant such as tube shunt blockage not related to implant concealment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synthetic Tissue Substitute | Experimental | Device: CorNeat EverPatchCorneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Aged ≥ 18 and ≤ 80 years on screening day
- Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.
- Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
- Adequate tear film and lid function
Key exclusion criteria (15 listed)
- Current retinal detachment
- Active ocular or orbital infection
- 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
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 EverPatchCovering Ophthalmic Implants | Device | Synthetic Tissue Substitute |
Primary outcome
Number of treatment-related adverse events
Time frame: up to 12 months
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events
2 secondary outcomes
Conjunctival integrity
Time frame: up to 12 months
Stability in patch dimensions
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorNeat EverPatch in people with Glaucoma Eye and Tissue Breakdown, run by CorNeat Vision Ltd. at 6 sites in 3 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 7 inclusion and 15 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Kenya, Canada, France. 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?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Number of treatment-related adverse events (time frame: up to 12 months). 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 7 Sep 2023; AzTrials last refreshed its copy on 3 Nov 2026.