Age Related Macular DegenerationSURViVORNCT04697095
Survival of Monocytes Collected From Patients With Atrophic AMD in Retinal Pigmented Epithelium Explants
A study testing Blood samples in people with Age Related Macular Degeneration, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Age-related macular degeneration (AMD) affects 2 million people in France and is the main cause of irreversible blindness in France. All patients initially have an early form of the disease. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Blood samples
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2022to 2 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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:
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69003
Christelle GILLI, Dr, +33472119513, christelle.gilli@chu-lyon.fr
Christelle GILLI, Dr
- Recruiting
Service d'ophtalmologie-HOSPICES CIVILS DE LYON - Hôpital de la Croix-Rousse
Lyon, 69004
Thibaud Mathis, MD, 4 26 10 93 22 ext. +33, thibaud.mathis@chu-lyon.fr
Christelle SZATANEK, 4 26 73 27 24 ext. +33, christelle.szatanek@chu-lyon.fr
About this study
Age-related macular degeneration (AMD) affects 2 million people in France and is the main cause of irreversible blindness in France. All patients initially have an early form of the disease. This early form can evolve in two different ways: the atrophic form, which progresses slowly, and the exudative or neovascular form, which has a more rapid evolution. While there are treatments for the exudative form of the disease, there is currently no therapy for the atrophic form of AMD. Recently, it has been demonstrated in atrophic AMD that there is accumulation of inflammatory cells, monocytes, in the sub-retinal space. This space is located between the retinal pigment epithelium (RPE) and photoreceptors. It is physiologically devoid of immune cells (immune privilege). Monocytes secrete many pro-inflammatory molecules, such as cytokines. Some cytokines (IL-1, IL6 and TNF) have a deleterious role on RPE and photoreceptors in mouse models. The identification of specific cytokines would help to better understand this disease and consider potential targeted therapies. Our project is based on the hypothesis that monocytes extracted from patients with AMD have a superior survival on RPE compared to monocytes extracted from healthy patients (without retinal pathology), and more particularly in atrophic forms of AMD. The main aim of this study is to compare the survival of monocytes extracted from patients with atrophic AMD to monocytes extracted from patients without retinal pathology (control) on retinal pigment epithelial cell lines (ARPE-19). Survival will be evaluated by automated counting of monocytes after 24 hours of culture on ARPE-19 after specific immunostaining of monocytes. If the survival of monocytes from patients with the late form of AMD is increased then therapy directly targeting this pathological accumulation of monocytes could be considered. Moreover, the identification of increased secretion of certain cytokines and the demonstration of their deleterious effect on retinal physiology could lead to targeted therapies against them.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Blood samples
- Keywords
- Wet AMD, Dry AMD, Monocytes, Survival, Cytokines, Inflammation, Blood Samples
- Medical subject headings
- Macular Degeneration, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
: 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.
| Study group | Role | What they receive |
|---|---|---|
| early / intermediate AMD without neovessels and without macular atrophy | Experimental | Not described Receives: Other: Blood samples |
| Late exsudative AMD with neovessels | Experimental | Not described Receives: Other: Blood samples |
| Late AMD with macular atrophy without neovessels | Experimental | Not described Receives: Other: Blood samples |
| Patientes with No AMD | Sham comparator | Not described Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Survival will be evaluated by automated counting of monocytes
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Comparison of human monocyte survival on ARPE-19 cell lines between different groups of patients with AMD or according to severity of disease.
Survival will be assessed by automated counting of monocytes on the culture plate after specific immunostaining of the monocytes.
Measured: through study completion, an average of 1 year
Comparison of alterations in ARPE-19 cells lines after culture by human monocytes:
Comparison of alterations in ARPE-19 cells lines after culture by human monocytes:
- Between the atrophic AMD group and the control group,
- With respect to the stage of the AMD (early / intermediate AMD, exudative or atrophic AMD),
- With respect to the evolving profile of atrophic AMD defined by autofluorescence examination,
- With respect to the severity of the clinical involvement of atrophic AMD,
- With respect to the recognized risk factors of the disease (age, sex, smoking status and obesity).
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.
Measured: through study completion, an average of 1 year
To compare the secretion of IL1 from patient's monocytes:
To compare the secretion of IL1 from patient's monocytes:
- Between the atrophic AMD group and the control group, With respect to the stage of the AMD (early / intermediate AMD, exudative or atrophic AMD),
- With respect to the evolving profile of atrophic AMD defined by autofluorescence examination,
- With respect to the severity of the clinical involvement of atrophic AMD,
- With respect to the recognized risk factors of the disease (age, sex, smoking status and obesity).
The secretory activity of monocytes on the following cytokines will be evaluated : IL1, IL6 and TNF by two techniques: qPCR and ELISA.
Measured: through study completion, an average of 1 year
To compare the secretion of IL6 from patient's monocytes:
To compare the secretion of IL6 from patient's monocytes:
Measured: through study completion, an average of 1 year
To compare the secretion of TNF from patient's monocytes
To compare the secretion of TNF from patient's monocytes:
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jun 2022
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibaud Mathis, MD, Principal investigator, Service d'Ophtalmologie Hospices Civils de Lyon Hôpital de la Croix Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697095
- Sponsor's protocol ID
- 69HCL20_0027
- Acronym
- SURViVOR
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of Monocytes Collected From Patients With Atrophic AMD in Retinal Pigmented Epithelium Explants
- ClinicalTrials.gov ID
- NCT04697095
- Acronym / sponsor ID
- SURViVOR / 69HCL20_0027
- Conditions
- Age Related Macular Degeneration
- Keywords
- Wet AMD, Dry AMD, Monocytes, Survival, Cytokines, Inflammation, Blood Samples
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 6 Jan 2021 (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.
Age-related macular degeneration (AMD) affects 2 million people in France and is the main cause of irreversible blindness in France. All patients initially have an early form of the disease. This early form can evolve in two different ways: the atrophic form, which progresses slowly, and the exudative or neovascular form, which has a more rapid evolution. While there are treatments for the exudative form of the disease, there is currently no therapy for the atrophic form of AMD. Recently, it has been demonstrated in atrophic AMD that there is accumulation of inflammatory cells, monocytes, in the sub-retinal space. This space is located between the retinal pigment epithelium (RPE) and photoreceptors. It is physiologically devoid of immune cells (immune privilege). Monocytes secrete many pro-inflammatory molecules, such as cytokines. Some cytokines (IL-1, IL6 and TNF) have a deleterious role on RPE and photoreceptors in mouse models. The identification of specific cytokines would help to better understand this disease and consider potential targeted therapies. Our project is based on the hypothesis that monocytes extracted from patients with AMD have a superior survival on RPE compared to monocytes extracted from healthy patients (without retinal pathology), and more particularly in atrophic forms of AMD. The main aim of this study is to compare the survival of monocytes extracted from patients with atrophic AMD to monocytes extracted from patients without retinal pathology (control) on retinal pigment epithelial cell lines (ARPE-19). Survival will be evaluated by automated counting of monocytes after 24 hours of culture on ARPE-19 after specific immunostaining of monocytes. If the survival of monocytes from patients with the late form of AMD is increased then therapy directly targeting this pathological accumulation of monocytes could be considered. Moreover, the identification of increased secretion of certain cytokines and the demonstration of their deleterious effect on retinal physiology could lead to targeted therapies against them.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| early / intermediate AMD without neovessels and without macular atrophy | Experimental | Other: Blood samples |
| Late exsudative AMD with neovessels | Experimental | Other: Blood samples |
| Late AMD with macular atrophy without neovessels | Experimental | Other: Blood samples |
| Patientes with No AMD | Sham comparator | Other: Blood samples |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Either the same type of AMD defined according to the modified international AREDS study (Ferris et al. 2013),
Key exclusion criteria (12 listed)
- 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,
- Patient with atrophic AMD in one eye and exudative AMD in the other eye,
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 |
|---|---|---|
| Blood samples: 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. | Other | Late AMD with macular atrophy without neovessels, Late exsudative AMD with neovessels, Patientes with No AMD, early / intermediate AMD without neovessels and without macular atrophy |
Primary outcome
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
5 secondary outcomes
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
Comparison of alterations in ARPE-19 cells lines after culture by human monocytes:
Time frame: 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 IL6 from patient's monocytes:
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Thibaud Mathis, MD principal investigator
Service d'Ophtalmologie Hospices Civils de Lyon Hôpital de la Croix Rousse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Age Related Macular Degeneration, run by Hospices Civils de Lyon at 2 sites 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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibaud Mathis, MD (4 26 10 93 22 ext. +33, thibaud.mathis@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.