Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
Primary Purpose
Diabetic Retinopathy, Retinal Vein Occlusion
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sampling of ophthalmic liquid
Sponsored by
About this trial
This is an interventional other trial for Diabetic Retinopathy
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)
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with ophthalmic surgery
Arm Description
Outcomes
Primary Outcome Measures
sCD160 concentration in the vitreous humor
ELISA test
sCD160 concentration in the aqueous humor
ELISA test
Secondary Outcome Measures
sCD160 concentration in the serum
ELISA test
Diabetic retinopathy severity
Angiography
Vascular endothelial growth factor (VEGF)
LUMINEX test
Placenta Growth Factor-1(PlGF)
LUMINEX test
Stromal cell-derived factor 1 (SDF-1)
LUMINEX test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03680794
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Vein Occlusion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with ophthalmic surgery
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
sampling of ophthalmic liquid
Intervention Description
aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery
Primary Outcome Measure Information:
Title
sCD160 concentration in the vitreous humor
Description
ELISA test
Time Frame
Day 0
Title
sCD160 concentration in the aqueous humor
Description
ELISA test
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
sCD160 concentration in the serum
Description
ELISA test
Time Frame
Day 0
Title
Diabetic retinopathy severity
Description
Angiography
Time Frame
Day 0
Title
Vascular endothelial growth factor (VEGF)
Description
LUMINEX test
Time Frame
Day 0
Title
Placenta Growth Factor-1(PlGF)
Description
LUMINEX test
Time Frame
Day 0
Title
Stromal cell-derived factor 1 (SDF-1)
Description
LUMINEX test
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl ARNDT
Phone
326787090
Ext
0033
Email
carndt@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
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