CD160 Expression in Corneal Vessels

• Sponsor: CHU de Reims (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05009407
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Despite improvements in corneal transplantation, anti-angiogenic and anti-lymphangiogenic factors remain to be be identified. CD160 is an anti-angiogenic target: its expression seems to be restricted to some immune cells and to activated endothelial cells. We hypothesized that CD160 is expressed in blood and lymphatic human corneal neovessels and is involved in corneal graft rejection pathogenesis

Condition or Disease	Intervention/Treatment	Phase
Corneal Graft Rejection; CD160; Angiogenesis; Lymphangiogenesis	Biological: Immunohistochemistry and clinical analyses on patients and corneas

Detailed Description

After informed consent, patients enrolled for corneal graft surgery at the Robert Debré University Hospital, Reims, France, will be included.

Routine general and eye examination including cornea photographs will be performed.

During surgery, a quarter of patients' cornea and of donors' corneoscleral rim will be spared for immunohistochemistry analyzes.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CD160 Ans Corneal Graft: Expression in Corneal Vessels
• Anticipated Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
HOSTS patients ongoing corneal transplantation procedure which a full-thickness cornea from the host is replaced by a graft from a donor	Biological: Immunohistochemistry and clinical analyses on patients and corneas; Immunohistochemistry and clinical analyses on patients and corneas
DONORS grafts from donors that would be analyzed	Biological: Immunohistochemistry and clinical analyses on patients and corneas; Immunohistochemistry and clinical analyses on patients and corneas

Outcome Measures

Primary Outcome Measures

1. Micro-vascular densities [1 year]

   neovascularization scores quantification of blood (anti-ERG+/anti-D2-40-) and lymphatic (anti-ERG+/anti-D2-40+) vascular structures ; Percentages of those vascular structures marked with anti-CD160

Secondary Outcome Measures

1. Percentages of those vascular structures marked with anti-CD160 and/or CD105 and/or aSMA [1 year]

2. Evaluation of clinical blood vascular densities on photographs with help of ImageJ software [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

inclusion criteria :

• 18-year-old or more patients

• enrolled for penetrating keratoplasty or deep anterior lamellar keratoplasty surgeries at the Robert Debré University Hospital, Reims, France

• considered able to give an informed written consent exclusion criteria :

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damien JOLLY	Reims		France

Sponsors and Collaborators

• CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT05009407
• Other Study ID Numbers: PO21062
• First Posted: Aug 17, 2021
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CHU de Reims: Corneal Graft Rejection; CD160; Angiogenesis; lymphangiogenesis

Study Results

No Results Posted as of Aug 17, 2021