Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03680794 |
Other study ID # |
PA18053 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 27, 2018 |
Est. completion date |
February 1, 2025 |
Study information
Verified date |
October 2022 |
Source |
CHU de Reims |
Contact |
Carl ARNDT |
Phone |
326787090 |
Email |
carndt[@]chu-reims.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.