Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
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|ClinicalTrials.gov Identifier: NCT03680794|
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
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||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
|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
- sCD160 concentration in the vitreous humor [ Time Frame: Day 0 ]ELISA test
- sCD160 concentration in the aqueous humor [ Time Frame: Day 0 ]ELISA test
- sCD160 concentration in the serum [ Time Frame: Day 0 ]ELISA test
- Diabetic retinopathy severity [ Time Frame: Day 0 ]Angiography
- Vascular endothelial growth factor (VEGF) [ Time Frame: Day 0 ]LUMINEX test
- Placenta Growth Factor-1(PlGF) [ Time Frame: Day 0 ]LUMINEX test
- Stromal cell-derived factor 1 (SDF-1) [ Time Frame: Day 0 ]LUMINEX test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680794
|Contact: Carl ARNDT||326787090 ext email@example.com|
|Reims, France, 51092|
|Contact: Damien JOLLY 326788472 ext 33 firstname.lastname@example.org|