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.

Corneal Inflammation Clinical Trial

— 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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05667337
• Other study ID #: 20.017
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2026
• Est. completion date: June 1, 2040

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2040
• Est. primary completion date: January 1, 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Inflammation
• Deep Anterior Lamellar Keratoplasty
• Inflammation
• Keratitis

Intervention

Device:
• CLP-PEG-MPC
Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique

Procedure:
• Human donor cornea penetrating keratoplasty
Implantation of a human donor cornea graft utilizing PKP surgical technique

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Maisonneuve-Rosemont Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conjunctival inflammation	bulbar conjunctival inflammation (scale 0-none to 4-worse)	24 months
Primary	intraocular inflammation	anterior uveitis (SUN classification of cell and flare for anterior uveitis)	24 months
Primary	complications	occurence of implant-related complications	24 months
Primary	visual acuity - uncorrected	uncorrected visual acuity	24 months
Primary	visual acuity - best-spectacle correction	best-spectacle corrected visual acuity	24 months
Secondary	ocular pain	intensity of ocular pain and discomfort (questions 1,3, 10, 11 and 12 from Ocular Surface Disease Index questionnaire)	24 months
Secondary	corneal thickness	central corneal pachymetry	24 months
Secondary	corneal sensation	Central corneal esthesiometry using Cochet-Bonnet esthesiometer	24 months
Secondary	Refraction	eye refractive error	24 months