Clinical trial NCT03680794: Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
Official title: sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Retinal Vein Occlusion
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: sCD160 concentration in the vitreous humor
timeFrame: Day 0
measure: sCD160 concentration in the aqueous humor
timeFrame: Day 0
Secondary outcomes:
measure: sCD160 concentration in the serum
timeFrame: Day 0
measure: Diabetic retinopathy severity
timeFrame: Day 0
measure: Vascular endothelial growth factor (VEGF)
timeFrame: Day 0
measure: Placenta Growth Factor-1(PlGF)
timeFrame: Day 0
measure: Stromal cell-derived factor 1 (SDF-1)
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References: