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NCT Number: NCT03680794

Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Embolism and Thrombosis Endocrine System Diseases Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

Location status: Recruiting

Location contact

Damien JOLLY

CONTACT

[email protected]

326788472 ext. 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

sampling of ophthalmic liquid

Other

aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Carl ARNDT

CONTACT

[email protected]

326787090 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Sep 21, 2018
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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