Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sampling of ophthalmic liquid.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy, Retinal Vein Occlusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
Overview
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
- Other sampling of ophthalmic liquid
aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery
Primary outcome measures
- sCD160 concentration in the vitreous humor [Time frame: Day 0]
- sCD160 concentration in the aqueous humor [Time frame: Day 0]
Secondary outcome measures (5)
- sCD160 concentration in the serum [Time frame: Day 0]
- Diabetic retinopathy severity [Time frame: Day 0]
- Vascular endothelial growth factor (VEGF) [Time frame: Day 0]
- Placenta Growth Factor-1(PlGF) [Time frame: Day 0]
- Stromal cell-derived factor 1 (SDF-1) [Time frame: Day 0]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Chu Reims — Reims
Identifiers
NCT: NCT03680794 · PA18053