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

Sponsor

CHU de Reims (Other)

Overall Status

Unknown status

CT.gov ID

NCT03680794

Collaborator

(none)

120

Enrollment

Location

Arm

43.2

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Retinal Vein Occlusion	Other: sampling of ophthalmic liquid	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 27, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

sCD160 concentration in the vitreous humor [Day 0]
ELISA test
sCD160 concentration in the aqueous humor [Day 0]
ELISA test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Reims	Reims		France	51092

Sponsors and Collaborators

CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHU de Reims

ClinicalTrials.gov Identifier:

NCT03680794

Other Study ID Numbers:

PA18053

First Posted:

Sep 21, 2018

Last Update Posted:

Dec 16, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Retinal Vein Occlusion

Study Results

No Results Posted as of Dec 16, 2019