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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03680794
• Other study ID #: PA18053
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2018
• Est. completion date: February 1, 2025

Study information

• Verified date: October 2022
• Source: CHU de Reims
• Contact: Carl ARNDT
• Phone: 326787090
• Email: carndt[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

inclusion criteria :

• over 18 years old

• with social security affiliation

• willing to participate this study non-inclusion criteria :

• any prior (3 months) or concomitant treatment with anti-VEGF therapy, corticosteroids, or immunosuppressive agents

• any history of previous vitreoretinal surgery, ocular tumor, severe ocular trauma, severe intraocular, periocular infection, inflammation, or radiation

• any serious allergy to the fluorescein sodium for injection in angiography

• any history of previous systemic anti-VEGF treatment

• any history of inflammatory or auto-immune disease

• any active extraocular inflammation or infection in the last 4 weeks before surgery exclusion criteria :

• Patients with C-reactive protein CRP > 10mg/mL (serum sampling during surgery)

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Retinal Vein Occlusion

Intervention

Other:
• sampling of ophthalmic liquid
aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sCD160 concentration in the vitreous humor	ELISA test	Day 0
Primary	sCD160 concentration in the aqueous humor	ELISA test	Day 0
Secondary	sCD160 concentration in the serum	ELISA test	Day 0
Secondary	Diabetic retinopathy severity	Angiography	Day 0
Secondary	Vascular endothelial growth factor (VEGF)	LUMINEX test	Day 0
Secondary	Placenta Growth Factor-1(PlGF)	LUMINEX test	Day 0
Secondary	Stromal cell-derived factor 1 (SDF-1)	LUMINEX test	Day 0