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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.

NCT ID: NCT05667337

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2040-06-01

Brief Summary

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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

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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

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High-risk Corneal Transplantation Corneal Blindess Corneal Inflammation Deep Anterior Lamellar Keratoplasty

Keywords

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cornea biosynthetic implants tissue regeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CLP-PEG-MPC DALK

Subjects having successfully undergone implantation of CLP-PEG-MPC implant using DALK technique

Group Type EXPERIMENTAL

CLP-PEG-MPC

Intervention Type DEVICE

Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique

HDC PKP

Subjects having undergone DALK conversion to PKP using a human donor cornea tissue

Group Type ACTIVE_COMPARATOR

Human donor cornea penetrating keratoplasty

Intervention Type PROCEDURE

Implantation of a human donor cornea graft utilizing PKP surgical technique

Interventions

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CLP-PEG-MPC

Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique

Intervention Type DEVICE

Human donor cornea penetrating keratoplasty

Implantation of a human donor cornea graft utilizing PKP surgical technique

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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20.017

Identifier Type: -

Identifier Source: org_study_id