Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
82
1 country
1
Study Start
November 22, 2017
Actual (reported)Primary Completion
September 8, 2020
Actual (reported)Study Completion
September 8, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 8, 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2017
Actual (reported)January 25, 2018
Actual (reported)February 1, 2018
Actual (reported)September 8, 2020
Actual (reported)September 8, 2020
Actual (reported)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).
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.
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
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)
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.
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
day of surgery
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD early / intermediate
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD exudative
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD atrophic
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital de la Croix-Rousse
Lyon, 69004, France
Roubeix C, Nous C, Augustin S, Ronning KE, Mathis T, Blond F, Lagouge-Roussey P, Crespo-Garcia S, Sullivan PM, Gautier EL, Reichhart N, Sahel JA, Burns ME, Paques M, Sorensen TL, Strauss O, Guillonneau X, Delarasse C, Sennlaub F. Splenic monocytes drive pathogenic subretinal inflammation in age-related macular degeneration. J Neuroinflammation. 2024 Jan 17;21(1):22. doi: 10.1186/s12974-024-03011-z.
Thibaud Mathis, MD
Hospices Civils de Lyon
82 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2018
First Posted
February 1, 2018
Study Start
November 22, 2017
Actual (reported)A blood and aqueous humor sample will be taken during cataract surgery in patients with cataract (control group)
Contact the study team to confirm eligibility.
Primary Completion
September 8, 2020
Actual (reported)Study Completion
September 8, 2020
Actual (reported)Last Updated
December 5, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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