Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedStudy Start
First participant enrolled
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 27, 2028
April 30, 2026
April 1, 2026
9.5 years
May 15, 2018
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
sCD160 concentration in the vitreous humor
ELISA test
Day 0
sCD160 concentration in the aqueous humor
ELISA test
Day 0
Secondary Outcomes (5)
sCD160 concentration in the serum
Day 0
Diabetic retinopathy severity
Day 0
Vascular endothelial growth factor (VEGF)
Day 0
Placenta Growth Factor-1(PlGF)
Day 0
Stromal cell-derived factor 1 (SDF-1)
Day 0
Study Arms (1)
Patients with ophthalmic surgery
EXPERIMENTALInterventions
aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery
Eligibility Criteria
You may qualify if:
- over 18 years old
- with social security affiliation
- 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
You may not qualify if:
- Patients with C-reactive protein CRP \> 10mg/mL (serum sampling during surgery)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu Reims
Reims, 51092, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
September 21, 2018
Study Start
June 27, 2018
Primary Completion (Estimated)
December 27, 2027
Study Completion (Estimated)
February 27, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04