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UnknownNCT03680794

Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies

sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
CHU de Reims · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

CD160 represents a new angiogenic factor as its specific engagement by an agonist monoclonal antibody directed against human CD160 reduced angiogenesis of endothelial cells with a distinct mechanism from current angiogenic therapies that target the VEGF/VEGF-R pathway. A soluble form of CD160, sCD160, has been found to be highly expressed in the vitreous and the sera of patients with severe diabetic retinopathies, and can now be dosed with help of an ELISA test. The investigators aim to evaluate the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations in the vitreous, the aqueous humour and the serum.

Detailed description

120 patients enrolled for ophthalmic surgery (cataract or posterior segment surgery (epiretinal membrane, macular hole, vitrectomy)) will be recruited in the Department of Ophthalmology, Robert Debré Hospital, Reims, France. Each patient will benefit a complete ophthalmologic examination, and either an aqueous sampling (cataract) or a vitreous sampling (posterior segment) along with a serum sampling at the beginning of the surgery. ELISA test will be performed on vitreous or aqueous samples in triplicates. Luminex will be performed on vitreous samples in order to determine the concentrations of several ischemia biomarkers (VEGF, PlGF, Platelet-derived growth factor (PDGF-B), SDF-1, Angpt2, InterIeukin IL-6, IL-8, CD105, Monocyte chemoattractant protein 1 (MCP-1), IL-10, interferon-inducible protein-10 ( IP-10), IL-1B and CD106, RAGE). Primary objective is: \- Evaluation of the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations of the vitreous or the aqueous humours. Secondary objectives are: * Evaluation of the association between diabetic retinopathies (patients with or without) and sCD160 concentrations of the vitreous, the aqueous humours and the sera. * Evaluation of the association between several vitreous biomarkers of ischaemia and sCD160 concentrations of the vitreous and the sera. * Evaluation of the association between sCD160 concentrations in the vitreous and the sera. * Evaluation of the association between sCD160 concentration in the aqueous humours and the sera.

Conditions

Interventions

TypeNameDescription
OTHERsampling of ophthalmic liquidaqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery

Timeline

Start date
2018-06-27
Primary completion
2024-12-01
Completion
2025-02-01
First posted
2018-09-21
Last updated
2022-10-20

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03680794. Inclusion in this directory is not an endorsement.