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

NCT04037917 | Terminated DMC

• 1 other identifier: SP-001
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 6

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).

Conditions

Glaucoma Eye; Tissue Breakdown

Outcome Measures

Primary Outcomes (1)

• Number of treatment-related adverse events

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

  up to 12 months

Secondary Outcomes (2)

• Conjunctival integrity

  up to 12 months

• Stability in patch dimensions

  up to 12 months

Study Arms (1)

Synthetic Tissue Substitute

EXPERIMENTAL

Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants

Device: CorNeat EverPatch

Interventions

CorNeat EverPatch DEVICE

Covering Ophthalmic Implants

Synthetic Tissue Substitute

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CorNeat Vision Ltd.: lead

Study Sites (6)

Prism Eye Institute

Oakville, Ontario, L6H OJ8, Canada

Location

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Hospital Foundation Adolphe De Rothschild

Paris, France

Location

Kwale eye hospital

Mombasa, Kenya

Location

Kenyatta National Hospital

Nairobi, Kenya

Location

Lions SightFirst Hospital

Nairobi, Kenya

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: July 30, 2019
• Study Start: December 11, 2020
• Primary Completion: April 30, 2023
• Study Completion: July 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); KE (3); CA (2)