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. (CLP-PEG-MPC)

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: High-risk Corneal Transplantation; Corneal Blindess; Corneal Inflammation; Deep Anterior Lamellar Keratoplasty
• Intervention / Treatment: Device: CLP-PEG-MPC; Procedure: Human donor cornea penetrating keratoplasty

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. adult age (18 years or older at the time of subject eligibility visit)
2. able to provide signed, informed consent
3. unilateral corneal opacity not involving the posterior corneal layers (Descemet membrane and endothelium) for which DALK is indicated
4. visual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness)
5. presence of at least one of the following high-risk criteria for corneal transplantation using a human cornea donor graft: 5i) inflammation 5ii) active infection 5iii) stromal neovascularization 5iv) neurotrophism 5v) autoimmune disease 5vi) previous DALK graft failure
6. availability for 24 months of postoperative follow-up

Exclusion Criteria:

1. Age under 18 years
2. Inability to give informed consent
3. Previous corneal perforation precluding DALK surgery
4. Endothelial pathology requiring penetrating keratoplasty
5. Limbal stem cell deficiency affection more than 50% of the limbus
6. Previous penetrating or endothelial keratoplasty
7. Bilateral blindness
8. Nystagmus
9. Uncontrolled glaucoma or intraocular pressure
10. Documented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole)
11. Documented amblyopia of surgical eye

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLP-PEG-MPC DALK; Subjects having successfully undergone implantation of CLP-PEG-MPC implant using DALK technique	Device: CLP-PEG-MPC; Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique
Active Comparator: HDC PKP; Subjects having undergone DALK conversion to PKP using a human donor cornea tissue	Procedure: Human donor cornea penetrating keratoplasty; Implantation of a human donor cornea graft utilizing PKP surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conjunctival inflammation	bulbar conjunctival inflammation (scale 0-none to 4-worse)	24 months
intraocular inflammation	anterior uveitis (SUN classification of cell and flare for anterior uveitis)	24 months
complications	occurence of implant-related complications	24 months
visual acuity - uncorrected	uncorrected visual acuity	24 months
visual acuity - best-spectacle correction	best-spectacle corrected visual acuity	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ocular pain	intensity of ocular pain and discomfort (questions 1,3, 10, 11 and 12 from Ocular Surface Disease Index questionnaire)	24 months
corneal thickness	central corneal pachymetry	24 months
corneal sensation	Central corneal esthesiometry using Cochet-Bonnet esthesiometer	24 months
Refraction	eye refractive error	24 months

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2026
• Primary Completion (Anticipated): January 1, 2040
• Study Completion (Anticipated): June 1, 2040

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: cornea; biosynthetic implants; tissue regeneration
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Corneal Diseases; Inflammation; Keratitis
• Other Study ID Numbers: 20.017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No