| Protocol No: | ECCT/20/08/01 | Date of Protocol: | 11-06-2020 |
| Study Title: | The CorNeat EverPatch – A First-In-Human Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts
|
| Study Objectives: | This clinical trial will assess the safety of the CorNeat EverPatch device |
| Laymans Summary: | This is a First in human study aimed to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts. Each subject will sign an informed consent form prior to any study activities. Subjects will be screened by the participating clinical sites’ clinical team (physician and study staff) during a screening visit and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled. Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam. Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.
|
| 1 | Glaucoma is a group of eye conditions that cause damage to the optic nerve and as a result constriction of the patient’s visual field. This damage is often caused by an abnormally high pressure in the eye. Available treatments, such as medication, laser treatment, or surgery, are focused on decreasing the eye pressure. One type of glaucoma surgery is an implantation of a glaucoma drainage device (GDD). In this procedure, the surgeon inserts a tube into the front part of the eye, and the rest of the tube is implanted underneath the conjunctiva, the tissue that covers the white part of the eye, to allow a flow of fluid out of the eye. A recognized complication of GDD surgery is the wearing down of the conjunctiva covering the tube, which can cause discomfort, inflammation, and infection, and requires revision of the surgery or removal of the tube. In order to prevent this complication, surgeons today use a piece of tissue to conceal the tube. This tissue segment should maintain conjunctival integrity. All tissue that is in use today is derived from a biological source meaning that they are procured from cadavers or in some cases from animal cadavers and that they degrade over time and carry the risk of transmitting diseases. The CorNeat EverPatch is an artificial device that has been developed as an alternative to biological tissue patches. It has a mesh like microscopical structure that encourages cells to grow into it and therefore strongly attach it to the eye. This scaffold is designed to allow long-term retention and integrity. In this first-in-human study, patients will sign an informed consent form and will go through a number of tests such as eye exams, general information and demographic data questionnaires, medical history and concomitant medication collection, to see if they are suitable to participate in this study. Patients who will be found suitable for the study will be implanted with the CorNeat EverPatch as part of a glaucoma drainage device surgery and will be followed-up for 12 months. During the follow up period, patients will be asked to attend 9 clinic visits in which they will be examined in their operated eye and be assessed for any safety issues. |
| Abstract of Study: | First in human study to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts. Feefteen subjects will be enrolled after screening by the participating clinical sites’ clinical team (physician and study staff) during a screening visit. Each subject will sign the ICF prior to any study activities and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled. Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam. Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.
|