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出境医 / 临床实验 / CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases (NEOVASC-CD160)

CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases (NEOVASC-CD160)

Study Description
Brief Summary:

The aims of this study were

  • to analyze CD160 expression in both normal and pathological eyes from human adults
  • to evaluate association between CD160 presence on endothelial cells from blood vessels and retinal vascular disease

Condition or disease Intervention/treatment
Surgical Retinal Other: immunohistochemistry on Formalin fixed and paraffin embedded blocks

Detailed Description:

Anti-angiogenic agents stand first in the treatment of neovascular diseases of the retina. Intravitreal injections of anti-Vascular Endothelial Growth Factor (VEGF) agents have emerged over the past decade as the first line of treatment in some neovascular diseases of the retina. Nevertheless, anti-VEGF therapies suffer some limitations, among which a short time to recurrence (1 week to 3 months) of retinal neovascularization and an eroding biological effect after prolonged use and.

CD160 appeared in several experimental studies as a marker of activated endothelial cells, suggesting it could represent a promising target for novel anti-angiogenic.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases
Actual Study Start Date : January 2008
Actual Primary Completion Date : January 2017
Actual Study Completion Date : July 2017
Arms and Interventions
Group/Cohort Intervention/treatment
neovascular group
patients with diabetic retinopathy, retinal vein occlusion complicated with iris rubeosis or neovascular glaucoma, ocular ischaemic syndrome, neovascular glaucoma secondary to any ocular event or iris rubeosis secondary to retinal detachment
Other: immunohistochemistry on Formalin fixed and paraffin embedded blocks
non-neovascular group
patients without neovascular diseases or complications but who underwent events leading to eye surgery such as trauma, endophthalmitis, cellulitis, anterior perforation, corneal abscess or retinal detachment.
Other: immunohistochemistry on Formalin fixed and paraffin embedded blocks
Outcome Measures
Primary Outcome Measures :
  1. CD160 staining intensity score [ Time Frame: Day0 ]

    Formalin fixed and paraffin embedded blocks were used for immunohistochemistry using CD160.

    The immunolabelling was evaluated independently by 2 observers (CBR, AH) blinded to clinical data. The staining intensity (0: absent, 1: faint, 2: moderate, 3: strong) was assessed for CD160 immunolabelling.



Secondary Outcome Measures :
  1. CD105 staining intensity score [ Time Frame: Day0 ]

    Formalin fixed and paraffin embedded blocks were used for immunohistochemistry using CD105.

    The immunolabelling was evaluated independently by 2 observers (CBR, AH) blinded to clinical data. The staining intensity (0: absent, 1: faint, 2: moderate, 3: strong) was assessed for CD105 immunolabelling.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with surgical retinal
Criteria

inclusion criteria :

  • Patients with retinal surgery
  • Patients who agree to participate to the study
  • Major patient

exclusion criteria :

  • Patient under law protection
  • Minor patient
Contacts and Locations

Locations
Layout table for location information
France
Chu Reims
France, Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date January 2008
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2019)
CD160 staining intensity score [ Time Frame: Day0 ]
Formalin fixed and paraffin embedded blocks were used for immunohistochemistry using CD160. The immunolabelling was evaluated independently by 2 observers (CBR, AH) blinded to clinical data. The staining intensity (0: absent, 1: faint, 2: moderate, 3: strong) was assessed for CD160 immunolabelling.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 6, 2019)
CD105 staining intensity score [ Time Frame: Day0 ]
Formalin fixed and paraffin embedded blocks were used for immunohistochemistry using CD105. The immunolabelling was evaluated independently by 2 observers (CBR, AH) blinded to clinical data. The staining intensity (0: absent, 1: faint, 2: moderate, 3: strong) was assessed for CD105 immunolabelling.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases
Official Title CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases
Brief Summary

The aims of this study were

  • to analyze CD160 expression in both normal and pathological eyes from human adults
  • to evaluate association between CD160 presence on endothelial cells from blood vessels and retinal vascular disease
Detailed Description

Anti-angiogenic agents stand first in the treatment of neovascular diseases of the retina. Intravitreal injections of anti-Vascular Endothelial Growth Factor (VEGF) agents have emerged over the past decade as the first line of treatment in some neovascular diseases of the retina. Nevertheless, anti-VEGF therapies suffer some limitations, among which a short time to recurrence (1 week to 3 months) of retinal neovascularization and an eroding biological effect after prolonged use and.

CD160 appeared in several experimental studies as a marker of activated endothelial cells, suggesting it could represent a promising target for novel anti-angiogenic.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with surgical retinal
Condition Surgical Retinal
Intervention Other: immunohistochemistry on Formalin fixed and paraffin embedded blocks
Study Groups/Cohorts
  • neovascular group
    patients with diabetic retinopathy, retinal vein occlusion complicated with iris rubeosis or neovascular glaucoma, ocular ischaemic syndrome, neovascular glaucoma secondary to any ocular event or iris rubeosis secondary to retinal detachment
    Intervention: Other: immunohistochemistry on Formalin fixed and paraffin embedded blocks
  • non-neovascular group
    patients without neovascular diseases or complications but who underwent events leading to eye surgery such as trauma, endophthalmitis, cellulitis, anterior perforation, corneal abscess or retinal detachment.
    Intervention: Other: immunohistochemistry on Formalin fixed and paraffin embedded blocks
Publications * Henry A, Boulagnon-Rombi C, Menguy T, Giustiniani J, Garbar C, Mascaux C, Labrousse M, Milas C, Barbe C, Bensussan A, Durlach V, Arndt C. CD160 Expression in Retinal Vessels Is Associated With Retinal Neovascular Diseases. Invest Ophthalmol Vis Sci. 2018 Jun 1;59(7):2679-2686. doi: 10.1167/iovs.18-24021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 6, 2019)
75
Original Actual Enrollment Same as current
Actual Study Completion Date July 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

inclusion criteria :

  • Patients with retinal surgery
  • Patients who agree to participate to the study
  • Major patient

exclusion criteria :

  • Patient under law protection
  • Minor patient
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03940664
Other Study ID Numbers 2018Ao001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date May 2019

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