Trials / Withdrawn
WithdrawnNCT05667337
Open-label Prospective Clinical Trial Evaluating the Safety and Efficacy of Biosynthetic CLP-PEG-MPC Corneal Implants in Patients Undergoing High-risk Deep Anterior Lamellar Keratoplasty.
Étude Clinique Ouverte et Prospective évaluant la sécurité et l'efficacité de la cornée biosynthétique CLP-PEG-MPC Chez Les Patients nécessitant Une kératoplastie Lamellaire antérieure Profonde à Haut Risque.
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label and prospective clinical trial, in which a maximum of 5 eyes of 5 patients will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) surgery and will be followed up over 24 months.
Detailed description
This is a prospective open-label clinical trial of patients who will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) corneal transplantation surgery and be followed over 24 months. The primary objective is to demonstrate the safety and tolerability of CLP-PEG-MPC biosynthetic corneal implants. The secondary objective is to examine the preliminary efficacy of these implants to stimulate corneal tissue regeneration, provide optical clarity and improvement of vision. Randomization is not appropriate in a first-in-human pilot study. Blinding is not possible as surgeons can easily tell a cell-free implant apart from a donor allograft.
Conditions
- High-risk Corneal Transplantation
- Corneal Blindess
- Corneal Inflammation
- Deep Anterior Lamellar Keratoplasty
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CLP-PEG-MPC | Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique |
| PROCEDURE | Human donor cornea penetrating keratoplasty | Implantation of a human donor cornea graft utilizing PKP surgical technique |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2040-01-01
- Completion
- 2040-06-01
- First posted
- 2022-12-28
- Last updated
- 2022-12-28
Source: ClinicalTrials.gov record NCT05667337. Inclusion in this directory is not an endorsement.