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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy; Retinal Vein Occlusion
• Intervention / Treatment: Other: sampling of ophthalmic liquid

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carl ARNDT; Phone Number: 0033 326787090; Email: carndt@chu-reims.fr

Study Locations

• France
  • Reims, France, 51092
    • Recruiting
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with ophthalmic surgery	Other: sampling of ophthalmic liquid; aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sCD160 concentration in the vitreous humor	ELISA test	Day 0
sCD160 concentration in the aqueous humor	ELISA test	Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2018
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): February 1, 2025

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Diseases; Diabetic Retinopathy; Retinal Vein Occlusion
• Other Study ID Numbers: PA18053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No