Clinical trial NCT05667337: 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.
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
Overall status: WITHDRAWN
Phase: NA
Conditions: High-risk Corneal Transplantation
Corneal Blindess
Corneal Inflammation
Deep Anterior Lamellar Keratoplasty
Keywords: cornea
biosynthetic implants
tissue regeneration
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Maisonneuve-Rosemont Hospital
First posted: 2022-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: conjunctival inflammation
timeFrame: 24 months
measure: intraocular inflammation
timeFrame: 24 months
measure: complications
timeFrame: 24 months
measure: visual acuity - uncorrected
timeFrame: 24 months
measure: visual acuity - best-spectacle correction
timeFrame: 24 months
Secondary outcomes:
measure: ocular pain
timeFrame: 24 months
measure: corneal thickness
timeFrame: 24 months
measure: corneal sensation
timeFrame: 24 months
measure: Refraction
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: