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.

Not Applicable

Withdrawn

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

• Registration Number: NCT05667337
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study First Submitted: 2020-10-06
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Study Start: 2026-01-01
• Primary Completion: 2040-01-01
• Study Completion: 2040-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HDC PKP	Human donor cornea penetrating keratoplasty	Subjects having undergone DALK conversion to PKP using a human donor cornea tissue
CLP-PEG-MPC DALK	CLP-PEG-MPC	Subjects having successfully undergone implantation of CLP-PEG-MPC implant using DALK technique

Primary Outcome Measures

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

Secondary Outcome Measures

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