High-risk Corneal TransplantationCLP-PEG-MPCNCT05667337
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.
A study testing CLP-PEG-MPC and Human donor cornea penetrating keratoplasty in people with High-risk Corneal Transplantation and Corneal Blindess, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- High-risk Corneal Transplantation, Corneal Blindess, Corneal Inflammation
- What is being tested?
- CLP-PEG-MPC and Human donor cornea penetrating keratoplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2040
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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.
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.
Read the 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
- Being tested
- CLP-PEG-MPC, Human donor cornea penetrating keratoplasty
- Keywords
- cornea, biosynthetic implants, tissue regeneration
- Medical subject headings
- Keratitis, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLP-PEG-MPCDevice
Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique
Human donor cornea penetrating keratoplastyProcedure or surgery
Implantation of a human donor cornea graft utilizing PKP surgical technique
| Study group | Role | What they receive |
|---|---|---|
| CLP-PEG-MPC DALK | Experimental | Subjects having successfully undergone implantation of CLP-PEG-MPC implant using DALK technique Receives: Device: CLP-PEG-MPC |
| HDC PKP | Active comparator | Subjects having undergone DALK conversion to PKP using a human donor cornea tissue Receives: Procedure: Human donor cornea penetrating keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
conjunctival inflammation
bulbar conjunctival inflammation (scale 0-none to 4-worse)
Measured: 24 months
intraocular inflammation
anterior uveitis (SUN classification of cell and flare for anterior uveitis)
Measured: 24 months
complications
occurence of implant-related complications
Measured: 24 months
visual acuity - uncorrected
uncorrected visual acuity
Measured: 24 months
visual acuity - best-spectacle correction
best-spectacle corrected visual acuity
Measured: 24 months
Secondary outcomes (4)
ocular pain
intensity of ocular pain and discomfort (questions 1,3, 10, 11 and 12 from Ocular Surface Disease Index questionnaire)
Measured: 24 months
corneal thickness
central corneal pachymetry
Measured: 24 months
corneal sensation
Central corneal esthesiometry using Cochet-Bonnet esthesiometer
Measured: 24 months
Refraction
eye refractive error
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2040 (estimated)
- Study completion1 Jun 2040 (estimated)
Why it stopped: further biomaterial optimization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Corneal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Maisonneuve-Rosemont Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667337
- Sponsor's protocol ID
- 20.017
- Acronym
- CLP-PEG-MPC
- Status last verified
- Dec 2022
- First submitted
- 6 Oct 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05667337
- Acronym / sponsor ID
- CLP-PEG-MPC / 20.017
- Conditions
- High-risk Corneal Transplantation, Corneal Blindess, Corneal Inflammation, Deep Anterior Lamellar Keratoplasty
- Keywords
- cornea, biosynthetic implants, tissue regeneration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: further biomaterial optimization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Maisonneuve-Rosemont Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2040 (estimated)
- Study completion
- 1 Jun 2040 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CLP-PEG-MPC DALK | Experimental | Device: CLP-PEG-MPCSubjects having successfully undergone implantation of CLP-PEG-MPC implant using DALK technique |
| HDC PKP | Active comparator | Procedure: Human donor cornea penetrating keratoplastySubjects having undergone DALK conversion to PKP using a human donor cornea tissue |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLP-PEG-MPCImplantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique | Device | CLP-PEG-MPC DALK |
| Human donor cornea penetrating keratoplastyImplantation of a human donor cornea graft utilizing PKP surgical technique | Procedure or surgery | HDC PKP |
Primary outcome
conjunctival inflammation
Time frame: 24 months
bulbar conjunctival inflammation (scale 0-none to 4-worse)
intraocular inflammation
Time frame: 24 months
anterior uveitis (SUN classification of cell and flare for anterior uveitis)
complications
Time frame: 24 months
occurence of implant-related complications
visual acuity - uncorrected
Time frame: 24 months
uncorrected visual acuity
visual acuity - best-spectacle correction
Time frame: 24 months
best-spectacle corrected visual acuity
4 secondary outcomes
ocular pain
Time frame: 24 months
corneal thickness
Time frame: 24 months
corneal sensation
Time frame: 24 months
Refraction
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CLP-PEG-MPC and Human donor cornea penetrating keratoplasty in people with High-risk Corneal Transplantation and Corneal Blindess, run by Centre hospitalier de l'Université de Montréal (CHUM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conjunctival inflammation (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.