search
Back to results

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

Primary Purpose

Glaucoma Eye, Tissue Breakdown

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CorNeat EverPatch
Sponsored by
CorNeat Vision Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma Eye

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female
  2. Aged ≥ 18 and ≤ 80 years on screening day
  3. Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.
  4. Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
  5. Adequate tear film and lid function
  6. Visual acuity of light perception or better
  7. 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:

  1. Current retinal detachment
  2. Active ocular or orbital infection
  3. 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
  4. History of ocular or periocular malignancy
  5. History of extensive keloid formation
  6. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or component of the device
  7. Signs of current infection, including fever and current treatment with antibiotics
  8. Severe generalized disease that results in a life expectancy shorter than a year
  9. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
  10. Currently pregnant or breastfeeding
  11. 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
  12. Intraoperative complication that would preclude implantation of the study device.
  13. Any traumatic perforation
  14. Tissue gaps/weaknesses, resulting either from traumatic, disease-related or iatrogenic damage
  15. Loss of scleral integrity where use of tissue or substitutes is indicated.

Sites / Locations

  • Prism Eye Institute
  • University Health Network - Toronto Western Hospital
  • Hospital Foundation Adolphe De Rothschild
  • Kwale eye hospital
  • Kenyatta National Hospital
  • Lions SightFirst Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Synthetic Tissue Substitute

Arm Description

Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants

Outcomes

Primary Outcome Measures

Number of treatment-related adverse events
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events

Secondary Outcome Measures

Conjunctival integrity
Conjunctival integrity at the implantation should be 90% or more as measured by Slit lamp examination
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

Full Information

First Posted
May 15, 2019
Last Updated
September 3, 2023
Sponsor
CorNeat Vision Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04037917
Brief Title
First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CorNeat Vision Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Eye, Tissue Breakdown

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synthetic Tissue Substitute
Arm Type
Experimental
Arm Description
Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants
Intervention Type
Device
Intervention Name(s)
CorNeat EverPatch
Intervention Description
Covering Ophthalmic Implants
Primary Outcome Measure Information:
Title
Number of treatment-related adverse events
Description
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Conjunctival integrity
Description
Conjunctival integrity at the implantation should be 90% or more as measured by Slit lamp examination
Time Frame
up to 12 months
Title
Stability in patch dimensions
Description
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
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Prism Eye Institute
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H OJ8
Country
Canada
Facility Name
University Health Network - Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Hospital Foundation Adolphe De Rothschild
City
Paris
Country
France
Facility Name
Kwale eye hospital
City
Mombasa
Country
Kenya
Facility Name
Kenyatta National Hospital
City
Nairobi
Country
Kenya
Facility Name
Lions SightFirst Hospital
City
Nairobi
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs