Surgical RetinalNEOVASC-CD160NCT03940664
CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases
An observational study of Surgical Retinal, run by CHU de Reims at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Retinal
- What is being tested?
- immunohistochemistry on Formalin fixed and paraffin embedded blocks
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with surgical retinal
Who may be able to join
- Patients with retinal surgery
- Patients who agree to participate to the study
- Major patient
Who cannot join
- Patient under law protection
- Minor patient
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Surgical Retinal
- Being tested
- immunohistochemistry on Formalin fixed and paraffin embedded blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemistry on Formalin fixed and paraffin embedded blocksOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: immunohistochemistry on Formalin fixed and paraffin embedded blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD160 staining intensity score
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.
Measured: Day0
Secondary outcomes (1)
CD105 staining intensity score
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.
Measured: Day0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study startJan 2008
- Primary completionJan 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical RetinalStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940664
- Sponsor's protocol ID
- 2018Ao001
- Acronym
- NEOVASC-CD160
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29860454
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases
- ClinicalTrials.gov ID
- NCT03940664
- Acronym / sponsor ID
- NEOVASC-CD160 / 2018Ao001
- Conditions
- Surgical Retinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neovascular group | – | Other: immunohistochemistry on Formalin fixed and paraffin embedded blockspatients 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 |
| non-neovascular group | – | Other: immunohistochemistry on Formalin fixed and paraffin embedded blockspatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with surgical retinal
Key inclusion criteria (3 listed)
- Patients with retinal surgery
- Patients who agree to participate to the study
- Major patient
Key exclusion criteria (2 listed)
- Patient under law protection
- Minor patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemistry on Formalin fixed and paraffin embedded blocks | Other | neovascular group, non-neovascular group |
Primary outcome
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.
1 secondary outcome
CD105 staining intensity score
Time frame: Day0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Results publication: PubMed 29860454Henry 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.
- Individual participant dataSharing planned: Undecided
Related trials for Surgical Retinal
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
Recruiting
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Epiretinal Membrane
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Retinal, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD160 staining intensity score (time frame: Day0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.