Pivotal Trial for a Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants

NCT05469867 | Terminated DMC

• 1 other identifier: DMS-34948
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma Eye; Tissue Breakdown

Outcome Measures

Primary Outcomes (1)

• Safety Assessment

  The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation will be recorded

  Up to 12 months

Secondary Outcomes (1)

• Performance Assessment

  6 & 12 months post-op.

Study Arms (1)

Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants

EXPERIMENTAL

Device: CorNeat EverPatch

Interventions

CorNeat EverPatch DEVICE

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.

Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants

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 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.

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, specifically Oxybuprocaine hydrochloride, lidocaine, tropicamide, epinephrine, Iodine solution \& aromatic polycarbonate urethane
• 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)

Sponsors & Collaborators

• CorNeat Vision Ltd.: lead

Study Sites (1)

DaVinci Eye Care

Tbilisi, Georgia

Location

Study Design

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

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 22, 2022
• Study Start: August 16, 2022
• Primary Completion: September 24, 2023
• Study Completion: June 18, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)