NCT03680794

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress81%
Jun 2018Feb 2028

First Submitted

Initial submission to the registry

May 15, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

9.5 years

First QC Date

May 15, 2018

Last Update Submit

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

EXPERIMENTAL
Other: sampling of ophthalmic liquid

Interventions

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

Patients with ophthalmic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Diabetic RetinopathyRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVenous ThrombosisThrombosisEmbolism and Thrombosis

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

Locations