- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697095
Survival of Monocytes Collected From Patients With Atrophic AMD in Retinal Pigmented Epithelium Explants (SURViVOR)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thibaud Mathis, MD
- Phone Number: +33 4 26 10 93 22
- Email: thibaud.mathis@chu-lyon.fr
Study Contact Backup
- Name: Christelle SZATANEK
- Phone Number: +33 4 26 73 27 24
- Email: christelle.szatanek@chu-lyon.fr
Study Locations
-
-
-
Lyon, France, 69004
- Recruiting
- Service d'ophtalmologie-HOSPICES CIVILS DE LYON - Hôpital de la Croix-Rousse
-
Contact:
- Thibaud Mathis, MD
- Phone Number: +33 4 26 10 93 22
- Email: thibaud.mathis@chu-lyon.fr
-
Principal Investigator:
- Thibaud Mathis, MD
-
Contact:
- Christelle SZATANEK
- Phone Number: +33 4 26 73 27 24
- Email: christelle.szatanek@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
General criteria:
- Male or female older than 50,
- Provide written informed consent,
- Patient affiliated to French social security,
- Maximum sampling volume (care + research) per 30-day period to be adapted according to the weight of the patient
Specific criteria:
Patient presenting in both eyes:
- Either the same type of AMD defined according to the modified international AREDS study (Ferris et al. 2013),
- or early AMD in one eye and atrophic AMD in the other eye, the patient will therefore be defined as being atrophic
- or early AMD in one eye and exudative AMD in the other eye, the patient will therefore be defined as exudative,
- or no retinal pathology (control group).
Exclusion Criteria:
General criteria:
- Patient whose weight is less than 50kg,
- Adult patient under guardianship or curatorship or unable to express consent,
- Person deprived of liberty,
- Patient participating in an ongoing clinical trial during the inclusion visit,
Specific criteria:
- Patient with atrophic AMD in one eye and exudative AMD in the other eye,
- Patient presenting with chronic retinal pathologies other than AMD, defined according to the modified international AREDS study (Ferris et al. 2013) , in the included eye,
- Patient taking systemic drugs with an immunomodulatory action: immunosuppressants, immunomodulators, chemotherapy or corticosteroids,
- Patient with systemic pathologies modifying their immune status,
- Patient with a history of diabetes,
- Patient who had dynamic phototherapy on the included eye.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: early / intermediate AMD without neovessels and without macular atrophy
|
: The blood sample from all groups will be taken on the day of inclusion, in the ophthalmology department.
The patient will be cared for by a nurse and then taken to the collection room.
A 100 ml sample will be taken (10 tubes of 10 ml).
Blood samples will be labeled with the patient's identification number as part of the protocol.
They will be transported to the research laboratory in order to be picked up for monocyte extraction.
The purification of blood monocytes will be done.
In case of excess, the samples will be destroyed at the end of the study.
|
Experimental: Late exsudative AMD with neovessels
|
: The blood sample from all groups will be taken on the day of inclusion, in the ophthalmology department.
The patient will be cared for by a nurse and then taken to the collection room.
A 100 ml sample will be taken (10 tubes of 10 ml).
Blood samples will be labeled with the patient's identification number as part of the protocol.
They will be transported to the research laboratory in order to be picked up for monocyte extraction.
The purification of blood monocytes will be done.
In case of excess, the samples will be destroyed at the end of the study.
|
Experimental: Late AMD with macular atrophy without neovessels
|
: The blood sample from all groups will be taken on the day of inclusion, in the ophthalmology department.
The patient will be cared for by a nurse and then taken to the collection room.
A 100 ml sample will be taken (10 tubes of 10 ml).
Blood samples will be labeled with the patient's identification number as part of the protocol.
They will be transported to the research laboratory in order to be picked up for monocyte extraction.
The purification of blood monocytes will be done.
In case of excess, the samples will be destroyed at the end of the study.
|
Sham Comparator: Patientes with No AMD
|
: The blood sample from all groups will be taken on the day of inclusion, in the ophthalmology department.
The patient will be cared for by a nurse and then taken to the collection room.
A 100 ml sample will be taken (10 tubes of 10 ml).
Blood samples will be labeled with the patient's identification number as part of the protocol.
They will be transported to the research laboratory in order to be picked up for monocyte extraction.
The purification of blood monocytes will be done.
In case of excess, the samples will be destroyed at the end of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the survival of human monocytes on ARPE-19 cultures, between the group of patients with atrophic AMD and patient with no retinal pathology (control).
Time Frame: through study completion, an average of 1 year
|
Survival will be evaluated by automated counting of monocytes
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of human monocyte survival on ARPE-19 cell lines between different groups of patients with AMD or according to severity of disease.
Time Frame: through study completion, an average of 1 year
|
Survival will be assessed by automated counting of monocytes on the culture plate after specific immunostaining of the monocytes.
|
through study completion, an average of 1 year
|
Comparison of alterations in ARPE-19 cells lines after culture by human monocytes:
Time Frame: through study completion, an average of 1 year
|
Comparison of alterations in ARPE-19 cells lines after culture by human monocytes:
The alteration of ARPE-19 cells on expression level of OTX2, a ubiquitous transcription factor in EPR cells, will be studied. OTX2 is normally under-expressed in-vitro when a supernatant of lipopolysaccharide-activated monocytes is added to the culture medium. |
through study completion, an average of 1 year
|
To compare the secretion of IL1 from patient's monocytes:
Time Frame: through study completion, an average of 1 year
|
To compare the secretion of IL1 from patient's monocytes:
The secretory activity of monocytes on the following cytokines will be evaluated : IL1, IL6 and TNF by two techniques: qPCR and ELISA. |
through study completion, an average of 1 year
|
To compare the secretion of IL6 from patient's monocytes:
Time Frame: through study completion, an average of 1 year
|
To compare the secretion of IL6 from patient's monocytes:
|
through study completion, an average of 1 year
|
To compare the secretion of TNF from patient's monocytes
Time Frame: through study completion, an average of 1 year
|
To compare the secretion of TNF from patient's monocytes:
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thibaud Mathis, MD, Service d'Ophtalmologie Hospices Civils de Lyon Hôpital de la Croix Rousse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Age Related Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Hoffmann-La RocheRecruitingNeovascular Age Related Macular Degeneration | nAMDChina
-
Ocular Therapeutix, Inc.Duke University; FortreaRecruitingNeovascular Age-Related Macular DegenerationUnited States
-
Innostellar Biotherapeutics Co.,LtdRecruitingNeovascular Age-Related Macular DegenerationChina
-
Ocular Therapeutix, Inc.CompletedNeovascular Age-Related Macular DegenerationUnited States
-
Novartis PharmaceuticalsWithdrawn
Clinical Trials on Blood samples
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Centre Hospitalier Universitaire DijonCompletedPrimary Immune Thrombocytopenia (ITP)France
-
Institut BergoniéUnknown
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownPaediatric MalignanciesFrance
-
Centre Georges Francois LeclercCompleted
-
Centre Hospitalier Universitaire de NīmesCompletedHenoch Schönlein PurpuraFrance
-
Centre Hospitalier Universitaire DijonCompleted
-
Assistance Publique Hopitaux De MarseilleRecruitingPlastic SurgeriesFrance
-
University Hospital, BordeauxRecruitingSystemic Sclerosis | SclerodermaFrance
-
Centre Hospitalier Universitaire, AmiensCompleted