Diabetic Retinopathy, Retinal Vein Occlusion
Conditions
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.
Interventions
OTHERsampling of ophthalmic liquid
aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery
Sponsors
CHU de Reims
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sCD160 concentration in the vitreous humor | Day 0 | ELISA test |
| sCD160 concentration in the aqueous humor | Day 0 | ELISA test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
CONTACTCarl ARNDT
Outcome results
None listed