An interventional study of Blood samples in Age Related Macular Degeneration, sponsored by Hospices Civils de Lyon. Recruiting at 2 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Health services research
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 80 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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General criteria:
Specific criteria:
Patient presenting in both eyes:
Exclusion Criteria:
General criteria:
Specific criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Blood samples
Other: Blood samples
Other: Blood samples
Other: 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.
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
Time frame: through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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:
Time frame: 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:
Time frame: through study completion, an average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Dec 2027, 66 months after the start.
Of 104 non-industry interventional studies with no phase under Macular Degeneration, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 66 months is above that.
Counting every sponsor, half of 132 studies reached it within 37 months; a quarter within 17 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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