Open-label Prospective Clinical Trial Evaluating the Safe... | NCT05667337

Studies
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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Withdrawn

Last Update Posted

Dec 28, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

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

Interventions

CLP-PEG-MPC
Human donor cornea penetrating keratoplasty

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

further biomaterial optimization

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Jan 1, 2040Estimated

Completion Date

Jun 1, 2040Estimated

First Submitted Date

Oct 6, 2020

First Submission Date that Met QC Criteria

Dec 19, 2022

First Posted Date

Dec 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2022

Last Update Posted Date

Dec 28, 2022Actual

Name	Class
Maisonneuve-Rosemont Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CLP-PEG-MPC	Device	Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique	CLP-PEG-MPC DALK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
ocular pain	intensity of ocular pain and discomfort (questions 1,3, 10, 11 and 12 from Ocular Surface Disease Index questionnaire)	24 months
corneal thickness	central corneal pachymetry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.

ID	Term
D007634	Keratitis
D003316	Corneal Diseases