Measuring sCD160 in eye fluids and blood to look for links with ischemic retinal diseases
sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
This project tests whether sCD160 levels in the eye and blood are linked to ischemic retinal disease in adults having eye surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Reims) |
| Trial ID | NCT03680794 on ClinicalTrials.gov |
What this trial studies
Researchers will recruit 120 adults undergoing cataract or posterior-segment surgery at CHU Reims and collect aqueous or vitreous samples plus a blood sample at the start of surgery. sCD160 concentrations will be measured by ELISA in triplicate, and a panel of ischemia-related biomarkers will be measured in vitreous by Luminex. The main goal is to compare sCD160 levels between patients with and without ischemic retinopathies (including diabetic retinopathy and retinal vein occlusion) and to explore correlations between ocular and serum sCD160 and other biomarkers. Patients with recent anti-VEGF, steroid, or immunosuppressive treatments, active inflammation, or certain prior ocular surgeries are excluded to avoid confounding.
Who should consider this trial
Good fit: Adults (over 18) with social security affiliation who are scheduled for cataract or posterior-segment eye surgery and who have not had recent anti-VEGF, corticosteroid, or immunosuppressive treatments are ideal candidates.
Not a fit: People not undergoing eye surgery, those with recent anti-VEGF/steroid/immunosuppressive treatments, active systemic or ocular inflammation, or CRP > 10 mg/mL are unlikely to participate or benefit from the results.
Why it matters
Potential benefit: If successful, sCD160 measurement could become a biomarker to help identify or monitor ischemic retinal disease and point toward new therapeutic approaches targeting the CD160 pathway.
How similar studies have performed: Preclinical work shows anti-CD160 antibodies can reduce angiogenesis and sCD160 has been reported elevated in severe diabetic retinopathy, but clinical evidence directly linking sCD160 concentrations to ischemic retinopathies is limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Reims
- Chu Reims — Reims, France (Recruiting)
Study contacts
- Study coordinator: Carl ARNDT
- Email: carndt@chu-reims.fr
- Phone: 326787090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.