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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
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Retinal Vein Occlusion Other: sampling of ophthalmic liquid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. sCD160 concentration in the vitreous humor [ Time Frame: Day 0 ]
    ELISA test

  2. sCD160 concentration in the aqueous humor [ Time Frame: Day 0 ]
    ELISA test


Secondary Outcome Measures :
  1. sCD160 concentration in the serum [ Time Frame: Day 0 ]
    ELISA test

  2. Diabetic retinopathy severity [ Time Frame: Day 0 ]
    Angiography

  3. Vascular endothelial growth factor (VEGF) [ Time Frame: Day 0 ]
    LUMINEX test

  4. Placenta Growth Factor-1(PlGF) [ Time Frame: Day 0 ]
    LUMINEX test

  5. Stromal cell-derived factor 1 (SDF-1) [ Time Frame: Day 0 ]
    LUMINEX test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Carl ARNDT 326787090 ext 0033 carndt@chu-reims.fr

Locations
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France
Chu Reims Recruiting
Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03680794     History of Changes
Other Study ID Numbers: PA18053
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Retinal Vein Occlusion
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis