Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202007844168087 Date of Approval: 20/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The CorNeat EverPatch is a First-In-Human clinical study aimed at demonstrating the safety of a synthetic tissue substitute for covering a glaucoma tube shunt.
Official scientific title The CorNeat EverPatch is a First-In-Human clinical study aimed at demonstrating the safety of a synthetic tissue substitute for covering a glaucoma tube shunt.
Brief summary describing the background and objectives of the trial This clinical trial will assess the safety of the CorNeat EverPatch device. Primary Safety Endpoint: The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation of the CorNeat EverPatch device, 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
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/08/2020
Actual trial start date
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 13
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CorNeat EverPatch NA Permanent implant Subconjunctival implantation to conceal an ophthalmic implant or a glaucoma drainage device. 15
Control Group NA NA NA NA 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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 Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/06/2020 Kenyatta National Hospital University of Nairobi ERC
Ethics Committee Address
Street address City Postal code Country
Hospital Rd Nairobi 20723 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation of the CorNeat EverPatch device, and follow-up for up to 12 months will be 10% or less. 1 day, 1 week, 1, 2, 3, 6, 9, 12 months post implantation
Primary Outcome Conjunctival integrity at the implantation site will be 90% or more. 1 day, 1 week, 1, 2, 3, 6, 9 12 months post implantation
Secondary Outcome 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 6 and 12 months post implantation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lions SightFirst Hospital Kaptagat Rd Nairobi Kenya
Kenyatta National Hospital Hospital Rd Nairobi Kenya
Kwale Eye Centre Likoni-Ukunda Rd Mombasa Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
CorNeat Vision Hasheizaf 4 st. Raanana Israel
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CorNeat Vision Ltd Hasheizaf 4 st Raanana Israel Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lily Nyamai lilynyamai@gmail.com +254721710027 Kaptagat Rd
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Ivestigator
Role Name Email Phone Street address
Public Enquiries Gerry Tal gerry@corneat.com +972523562826 Hasheizaf 4, st
City Postal code Country Position/Affiliation
Raanana Israel VP clinical affairs
Role Name Email Phone Street address
Scientific Enquiries Gilad Litvin gilad@corneat.com +972503514057 Hasheizaf 4, st
City Postal code Country Position/Affiliation
Raanana Israel Chief Medical Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to share the de-identified individual participant data set to national and international policy makers, including the World Health Organization. Clinical Study Report,Informed Consent Form,Study Protocol August 2021 - August 2024 There will be controlled access to the data/documents with the gatekeepers being the Principal Investigator (PI) and the Chief Medical Officer of the Sponsor (CorNeat Vision), who will be responsible for deciding who may have access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information