Back to resultsOpen-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)
Primary Purpose
High-risk Corneal Transplantation, Corneal Blindess, Corneal Inflammation
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CLP-PEG-MPC
Human donor cornea penetrating keratoplasty
Sponsored by
About this trial
This is an interventional treatment trial for High-risk Corneal Transplantation focused on measuring cornea, biosynthetic implants, tissue regeneration
Eligibility Criteria
Inclusion Criteria: adult age (18 years or older at the time of subject eligibility visit) able to provide signed, informed consent unilateral corneal opacity not involving the posterior corneal layers (Descemet membrane and endothelium) for which DALK is indicated visual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness) 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 availability for 24 months of postoperative follow-up Exclusion Criteria: Age under 18 years Inability to give informed consent Previous corneal perforation precluding DALK surgery Endothelial pathology requiring penetrating keratoplasty Limbal stem cell deficiency affection more than 50% of the limbus Previous penetrating or endothelial keratoplasty Bilateral blindness Nystagmus Uncontrolled glaucoma or intraocular pressure Documented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole) Documented amblyopia of surgical eye
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CLP-PEG-MPC DALK
HDC PKP
Arm Description
Subjects having successfully undergone implantation of CLP-PEG-MPC implant using DALK technique
Subjects having undergone DALK conversion to PKP using a human donor cornea tissue
Outcomes
Primary Outcome Measures
conjunctival inflammation
bulbar conjunctival inflammation (scale 0-none to 4-worse)
intraocular inflammation
anterior uveitis (SUN classification of cell and flare for anterior uveitis)
complications
occurence of implant-related complications
visual acuity - uncorrected
uncorrected visual acuity
visual acuity - best-spectacle correction
best-spectacle corrected visual acuity
Secondary Outcome Measures
ocular pain
intensity of ocular pain and discomfort (questions 1,3, 10, 11 and 12 from Ocular Surface Disease Index questionnaire)
corneal thickness
central corneal pachymetry
corneal sensation
Central corneal esthesiometry using Cochet-Bonnet esthesiometer
Refraction
eye refractive error
Full Information
NCT ID
NCT05667337
First Posted
October 6, 2020
Last Updated
December 19, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Maisonneuve-Rosemont Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05667337
Brief Title
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.
Acronym
CLP-PEG-MPC
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
further biomaterial optimization
Study Start Date
January 1, 2026 (Anticipated)
Primary Completion Date
January 1, 2040 (Anticipated)
Study Completion Date
June 1, 2040 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Maisonneuve-Rosemont Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-risk Corneal Transplantation, Corneal Blindess, Corneal Inflammation, Deep Anterior Lamellar Keratoplasty
Keywords
cornea, biosynthetic implants, tissue regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Once qualified, subjects will be enrolled to receive a CLP-PEG-MPC implant by DALK. DALK surgery requires the precise dissection of the central 8 mm of the corneal stroma from the underlying posterior corneal layers (Dua layer, Descemet membrane and endothelium, approximately 30 microns thick). The dissection performed during DALK may perforate the posterior corneal layers, requiring conversion to full-thickness penetrating keratoplasty (PKP). Subjects who require conversion to PKP will receive a full-thickness human donor cornea as a safety measure and will be followed per protocol as a comparison group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLP-PEG-MPC DALK
Arm Type
Experimental
Arm Description
Subjects having successfully undergone implantation of CLP-PEG-MPC implant using DALK technique
Arm Title
HDC PKP
Arm Type
Active Comparator
Arm Description
Subjects having undergone DALK conversion to PKP using a human donor cornea tissue
Intervention Type
Device
Intervention Name(s)
CLP-PEG-MPC
Intervention Description
Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique
Intervention Type
Procedure
Intervention Name(s)
Human donor cornea penetrating keratoplasty
Intervention Description
Implantation of a human donor cornea graft utilizing PKP surgical technique
Primary Outcome Measure Information:
Title
conjunctival inflammation
Description
bulbar conjunctival inflammation (scale 0-none to 4-worse)
Time Frame
24 months
Title
intraocular inflammation
Description
anterior uveitis (SUN classification of cell and flare for anterior uveitis)
Time Frame
24 months
Title
complications
Description
occurence of implant-related complications
Time Frame
24 months
Title
visual acuity - uncorrected
Description
uncorrected visual acuity
Time Frame
24 months
Title
visual acuity - best-spectacle correction
Description
best-spectacle corrected visual acuity
Time Frame
24 months
Secondary Outcome Measure Information:
Title
ocular pain
Description
intensity of ocular pain and discomfort (questions 1,3, 10, 11 and 12 from Ocular Surface Disease Index questionnaire)
Time Frame
24 months
Title
corneal thickness
Description
central corneal pachymetry
Time Frame
24 months
Title
corneal sensation
Description
Central corneal esthesiometry using Cochet-Bonnet esthesiometer
Time Frame
24 months
Title
Refraction
Description
eye refractive error
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult age (18 years or older at the time of subject eligibility visit)
able to provide signed, informed consent
unilateral corneal opacity not involving the posterior corneal layers (Descemet membrane and endothelium) for which DALK is indicated
visual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness)
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
availability for 24 months of postoperative follow-up
Exclusion Criteria:
Age under 18 years
Inability to give informed consent
Previous corneal perforation precluding DALK surgery
Endothelial pathology requiring penetrating keratoplasty
Limbal stem cell deficiency affection more than 50% of the limbus
Previous penetrating or endothelial keratoplasty
Bilateral blindness
Nystagmus
Uncontrolled glaucoma or intraocular pressure
Documented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole)
Documented amblyopia of surgical eye
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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