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

• ClinicalTrials.gov Identifier: NCT03680794
• Recruitment Status: Unknown
• First Posted: September 21, 2018
• Last Update Posted: December 16, 2019
• Sponsor: CHU de Reims
• Information provided by (Responsible Party): CHU de Reims

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: N/A
• 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: June 27, 2018
• Estimated Primary Completion Date: December 1, 2021
• Estimated Study Completion Date: February 1, 2022

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Contacts

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

Locations

France

Chu Reims; Recruiting

Reims, France, 51092

Contact: Damien JOLLY 326788472 ext 33 djolly@chu-reims.fr

Sponsors and Collaborators

CHU de Reims

More Information

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT03680794
• Other Study ID Numbers: PA18053
• First Posted: September 21, 2018
• Last Update Posted: December 16, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:

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