An interventional study of blood and aqueous humor sampling in Macular Degeneration, Age-Related, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Health services research
Age-related macular degeneration (AMD) affects 2 million people in France. It characterized by progressive degeneration of the central area of the retina allowing detailed vision. It is the main cause of irreversible blindness in France. All patients initially present an early form, the latter can evolve in two different ways: the atrophic form, which progresses slowly, and the exudative or neovascular form, of more rapid evolution. While the treatment of exudative AMD has improved dramatically in recent years, there is currently no therapy for atrophic AMD. Recently, it has been demonstrated in atrophic AMD, an accumulation of inflammatory cells, macrophages, in the sub-retinal space. This space is located between the pigment epithelium (PE) and the photoreceptors. It is physiologically devoid of immune cells (immune privilege). Macrophages will secrete many pro-inflammatory molecules, such as cytokines. It has been shown in mouse models that some cytokines (IL-1beta, IL6 et TNFalpha) have a deleterious role on (PE) and photoreceptors. The identification of specific cytokines in the aqueous humor of patients with atrophic AMD would help to better understand this disease and consider potential targeted therapies. This study will be conducted in the ophthalmology department of the Croix-Rousse Hospital in Lyon. 80 patients will be recruited and divided into 4 groups: three experimental groups of 20 patients with : Early / Intermediate AMD, atrophic AMD or exudative AMD, and one control group of 20 patients without signs of AMD. Assays of the markers will be performed using the Luminex® technique on aqueous humor and blood samples collected for all patients during cataract surgery. The concentrations obtained in the aqueous humor will be normalized on their respective blood levels in order to confirm the intraocular secretion of these markers,. The identification of particular cytokine profiles in atrophic AMD compared to other forms of AMD would support emerging hypotheses of involvement of specific inflammatory cells in this pathology. There is currently no treatment available for atrophic AMD. If molecular screening identifies one or more specific biomarkers, targeted therapy may be considered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 82 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
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Patient willing and able to return to all clinical visits to the study and complete all related procedures.
the same type of AMD defined according to the international AREDS study modified (Ferris et al., 2013) no other ophthalmological pathology (control group).
Exclusion Criteria:
Patient participating in an ongoing clinical trial during the inclusion visit,
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.
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.
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.
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD early / intermediate
Other: blood and aqueous humor sampling
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD exudative
Other: blood and aqueous humor sampling
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD atrophic
Other: blood and aqueous humor sampling
A blood and aqueous humor sample will be taken during cataract surgery in patients with cataract (control group)
Other: blood and aqueous humor sampling
The blood sample will be centrifuged. The plasma will be recovered. Plasma and aqueous humor will be frozen and stored at -80° Celsius. The search of 27 markers of inflammation will be performed by the kit LUMINEX Bio-rad (Bio-Rad, M500KCAF0Y).
Comparison of concentrations of intraocular inflammation markers between the group of patients with atrophic AMD and the control group.
Aqueous humor sample will be collected during the cataract surgery in patient with atrophic AMD and in patient of control group. In order to identify and quantify intraocular inflammation markers in samples, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). This test allow identification of one or more of the following 27 inflammation markers: basic FGF, Eotaxin, G-CSF, GM-CSF, interferon (IFNγ), interleukin (IL1β, IL1ra, IL2, IL4, IL5, IL6, IL7, IL8, IL9, IL10, IL12, IL13 , IL15, IL17), IP10, MCP1, MIP1α, MIP1β, PDGF-BB, RANTES, TNFα and Vascular Endothelial Growth Factor (VEGF).
Time frame: day of surgery
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] between the group of patients with atrophic AMD and the control group.
Aqueous humor sample and the blood sample will be collected during the cataract surgery in patient with atrophic AMD and in patient of control group. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated. Each ratio will be compared between patients with atrophic AMD and patients of control group.
Time frame: day of surgery
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] between the different stages of AMD: early / intermediate, exudative or atrophic
Aqueous humor sample and the blood sample will be collected during the cataract surgery in patient with different stage of AMD : early / intermediate, exudative or atrophic. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated and compared between different stages of AMD: early / intermediate, exudative or atrophic.
Time frame: day of surgery
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] between the different types of atrophic AMD defined by autofluorescence exam (non-hyperautofluorescent or hyperautofluorescent form)
Autofluorescence exam allows in vivo mapping of lipofuscin distribution. Lipofuscin is a fluorophore of the retinal pigment epithelium. Autofluorescence represents in gray scale the spatial distribution of lipofuscin, and reflect the metabolic activity of the retinal pigment epithelium. Autofluorescence exam allows classification in different types of atrophic AMD. Autofluorescence exam was performed for all patients at the first visit. Aqueous humor sample and blood sample will be collected during the cataract surgery. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated, and compared between the different types of atrophic AMD.
Time frame: day of surgery
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] according to the macular atrophy area measured by autofluorescence in atrophic AMD.
Macular atrophy area is measured at first visit in autofluorescent exam. Aqueous humor sample and the blood sample will be collected during the cataract surgery. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated, and compared between the different size of macular atrophy area.
Time frame: day of surgery
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] according to the central retinal thickness measured by Optical Coherence Tomography (OCT) in atrophic AMD
OCT define precisely the retinal structures and their locations. Aqueous humor sample and the blood sample will be collected during the cataract surgery. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated, and compared between the different thickness of retina measured by OCT .
Time frame: day of surgery
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] according to the recognized risk factors of AMD
ratios of \[aqueous humor / blood\] concentrations of inflammation markers will be compared on age, female sex, smoking (number of pack-years), obesity (body mass index)
Time frame: day of surgery
Ran from Nov 2017 to primary completion in Sep 2020, 33 months.
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 33 months is below 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.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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