NCT05009407

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

August 3, 2021

Last Update Submit

February 17, 2026

Conditions

Keywords

Corneal Graft RejectionCD160Angiogenesislymphangiogenesis

Outcome Measures

Primary Outcomes (1)

  • Micro-vascular densities

    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

    1 year

Secondary Outcomes (2)

  • Percentages of those vascular structures marked with anti-CD160 and/or CD105 and/or aSMA

    1 year

  • Evaluation of clinical blood vascular densities on photographs with help of ImageJ software

    1 year

Study Arms (2)

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

DONORS

grafts from donors that would be analyzed

Biological: Immunohistochemistry and clinical analyses on patients and corneas

Interventions

Immunohistochemistry and clinical analyses on patients and corneas

DONORSHOSTS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18-year-old or more patients enrolled for penetrating keratoplasty or deep anterior lamellar keratoplasty surgeries at the Robert Debré University Hospital, Reims, France

You may qualify if:

  • year-old or more patients
  • enrolled for penetrating keratoplasty or deep anterior lamellar keratoplasty surgeries at the Robert Debré University Hospital, Reims, France

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Interventions

Immunohistochemistry

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 17, 2021

Study Start

April 21, 2021

Primary Completion

December 22, 2025

Study Completion

December 22, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations