First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute

  • STATUS
    Recruiting
  • End date
    Mar 17, 2022
  • participants needed
    10
  • sponsor
    CorNeat Vision Ltd.
Updated on 17 July 2021

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 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).

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

Details
Condition Glaucoma Eye, tissue breakdown, bilateral glaucoma, glaucoma in both eyes
Treatment CorNeat EverPatch
Clinical Study IdentifierNCT04037917
SponsorCorNeat Vision Ltd.
Last Modified on17 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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