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.

NCT05667337 | Withdrawn DMC

• 1 other identifier: 20.017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

cornea; biosynthetic implants; tissue regeneration

Outcome Measures

Primary Outcomes (5)

• conjunctival inflammation

  bulbar conjunctival inflammation (scale 0-none to 4-worse)

  24 months

• intraocular inflammation

  anterior uveitis (SUN classification of cell and flare for anterior uveitis)

  24 months

• complications

  occurence of implant-related complications

  24 months

• visual acuity - uncorrected

  uncorrected visual acuity

  24 months

• visual acuity - best-spectacle correction

  best-spectacle corrected visual acuity

  24 months

Secondary Outcomes (4)

• ocular pain

  24 months

• corneal thickness

  24 months

• corneal sensation

  24 months

• Refraction

  24 months

Study Arms (2)

CLP-PEG-MPC DALK

EXPERIMENTAL

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

Device: CLP-PEG-MPC

HDC PKP

ACTIVE COMPARATOR

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

Procedure: Human donor cornea penetrating keratoplasty

Interventions

CLP-PEG-MPC DEVICE

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

CLP-PEG-MPC DALK

Human donor cornea penetrating keratoplasty PROCEDURE

Implantation of a human donor cornea graft utilizing PKP surgical technique

HDC PKP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Maisonneuve-Rosemont Hospital: collaborator

MeSH Terms

Conditions

Keratitis; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: December 28, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): June 1, 2040
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share