Glaucoma EyeEverPatchNCT05469867
Pivotal Trial for a Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants
A study testing CorNeat EverPatch in people with Glaucoma Eye and Tissue Breakdown, run by CorNeat Vision Ltd. at 1 site in Georgia.
Trial summary
This clinical trial will assess the clinical safety and performance of the CorNeat EverPatch device used as a tissue substitute for concealment of artificial ocular implants. 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
- 12 participants
- Where
- 1 siteGeorgia
- Study dates
- 16 Aug 2022to 18 Jun 2024
- 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 glaucoma tube shunt or suture tags is indicated
- Patients with viable and intact conjunctiva
- Candidates must have the ability and willingness to provide a written informed consent, attend all scheduled visits and comply with study procedures
- Adequate tear film and lid function as indicated by Tear Film Breakup Time test - more than 5 seconds
- Visual acuity of light perception or better
- Female patients of childbearing age must agree to use an acceptable and effective method of contraception throughout the study, including the follow-up period, and have negative pregnancy test at screening.
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, specifically Oxybuprocaine hydrochloride, lidocaine, tropicamide, epinephrine, Iodine solution \& aromatic polycarbonate urethane
Show all 18Show 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
- Pregnant or breastfeeding female subjects
- Participation in any study involving an investigational drug or device within 30 days of the study or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device
- Any traumatic perforation of the globe OR tissue gaps/weaknesses, resulting either from traumatic, disease- related or iatrogenic damage OR loss of scleral integrity where use of tissue or substitutes is indicated
- Vulnerable populations
- Active drug or alcohol abuse or dependence that, in the opinion of the principle investigator, would interfere with adherence to study requirements
- Subjects with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (e.g. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, uncompensated cirrhosis, active upper GI tract ulceration, active inflammatory disease, malignancy under active treatment)
- Subjects who receive anti-coagulation treatment which cannot be interfered during the perioperative period
- Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes
- Subjects receiving chronic systemic immunosuppressants (e.g. steroids, cyclosporine etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Pivotal, Open Label, Multi-centre Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat EverPatch, A Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants
This clinical trial will assess the clinical safety and performance of the CorNeat EverPatch device used as a tissue substitute for concealment of artificial ocular implants.
Read the detailed description
A single arm, pivotal, open label, multi-centre clinical investigation to evaluate the clinical safety and performance of the CorNeat EverPatch, a synthetic tissue substitute for concealment of artificial ocular implants.
Subjects will sign a consent form and will be assessed for eligibility based on clinical examinations and medical history. Upon eligibility verification, subjects will be implanted with the investigational device as part of an ophthalmic surgery in which a concealment of an artificial implant is required. Clinical examinations at follow up will include slit lamp biomicroscopy, assessment of visual acuity and intra ocular pressure, and recording of concomitant medications and any safety issues. Follow up visits will be performed at 1 week, 1-, 2-, 3-, 6-, 9- and 12-months post-op.
- 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
The CorNeat EverPatch will be implanted subconjunctivally over an ocular implant (e.g. glaucoma shunt, exposed suture tags) and fixed to the eye wall. The overlying conjunctiva will be closed over the patch.
| Study group | Role | What they receive |
|---|---|---|
| Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants | Experimental | Not described Receives: Device: CorNeat EverPatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation will be recorded
Measured: Up to 12 months
Secondary outcomes (1)
Performance Assessment
Tube or suture exposure will be detected by slit-lamp Biomicroscopy throughout the entire follow up period and incidence will be calculated. Prevention of tube or suture exposure associated with conjunctival erosion and graft melting should be demonstrated in at least 90% of the patients.
Measured: 6 & 12 months post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start16 Aug 2022
- Primary completion24 Sep 2023
- Study completion18 Jun 2024
Why it stopped: Sponsor decided to stop the trial due to a shift in strategic business priorities.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT05469867
- Sponsor's protocol ID
- DMS-34948
- Acronym
- EverPatch
- Status last verified
- Jun 2024
- First submitted
- 18 Jul 2022
- Last updated
- 27 Jun 2024
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Pivotal, Open Label, Multi-centre Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat EverPatch, A Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants
- ClinicalTrials.gov ID
- NCT05469867
- Acronym / sponsor ID
- EverPatch / DMS-34948
- Conditions
- Glaucoma Eye, Tissue Breakdown
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to stop the trial due to a shift in strategic business priorities.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CorNeat Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 22 Jul 2022 (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.
This clinical trial will assess the clinical safety and performance of the CorNeat EverPatch device used as a tissue substitute for concealment of artificial ocular implants.
Detailed description
A single arm, pivotal, open label, multi-centre clinical investigation to evaluate the clinical safety and performance of the CorNeat EverPatch, a synthetic tissue substitute for concealment of artificial ocular implants.
Subjects will sign a consent form and will be assessed for eligibility based on clinical examinations and medical history. Upon eligibility verification, subjects will be implanted with the investigational device as part of an ophthalmic surgery in which a concealment of an artificial implant is required. Clinical examinations at follow up will include slit lamp biomicroscopy, assessment of visual acuity and intra ocular pressure, and recording of concomitant medications and any safety issues. Follow up visits will be performed at 1 week, 1-, 2-, 3-, 6-, 9- and 12-months post-op.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants | Experimental | Device: CorNeat EverPatch |
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 screening day
- Concealment of glaucoma tube shunt or suture tags is indicated
- Patients with viable and intact conjunctiva
- Candidates must have the ability and willingness to provide a written informed consent, attend all scheduled visits and comply with study procedures
Key exclusion criteria (18 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 EverPatchThe CorNeat EverPatch will be implanted subconjunctivally over an ocular implant (e.g. glaucoma shunt, exposed suture tags) and fixed to the eye wall. The overlying conjunctiva will be closed over the patch. | Device | Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants |
Primary outcome
Safety Assessment
Time frame: Up to 12 months
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation will be recorded
1 secondary outcome
Performance Assessment
Time frame: 6 & 12 months post-op.
Results and safety
The study was stopped early (reason given: Sponsor decided to stop the trial due to a shift in strategic business priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- 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.
1 site in 1 country: 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 1 site in Georgia.
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 18 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. 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 decided to stop the trial due to a shift in strategic business priorities.). 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?
Safety Assessment (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 27 Jun 2024.