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

Not Applicable

Recruiting

• Conditions: Diabetic Retinopathy; Retinal Vein Occlusion
• Interventions: Other: sampling of ophthalmic liquid

• Registration Number: NCT03680794
• Lead Sponsor: CHU de Reims

Brief 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.

Study Timeline

• Study First Submitted: 2018-05-15
• Study Start: 2018-06-27
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with ophthalmic surgery	sampling of ophthalmic liquid	-

Primary Outcome Measures

Name	Time	Method
sCD160 concentration in the aqueous humor	Day 0	ELISA test
sCD160 concentration in the vitreous humor	Day 0	ELISA test

Secondary Outcome Measures

Name	Time	Method
Diabetic retinopathy severity	Day 0	Angiography
Vascular endothelial growth factor (VEGF)	Day 0	LUMINEX test
sCD160 concentration in the serum	Day 0	ELISA test
Stromal cell-derived factor 1 (SDF-1)	Day 0	LUMINEX test
Placenta Growth Factor-1(PlGF)	Day 0	LUMINEX test

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France