Comparison of Cytokine Profiles in Aqueous Humor of Patients With Age Related Macular Degeneration (AMD)
2 other identifiers
interventional
82
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2017
CompletedFirst Submitted
Initial submission to the registry
January 25, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2020
CompletedDecember 5, 2025
November 1, 2025
2.8 years
January 25, 2018
November 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
AMD early / intermediate
OTHERA blood and aqueous humor sample will be taken during cataract surgery in patients with AMD early / intermediate
AMD exudative
OTHERA blood and aqueous humor sample will be taken during cataract surgery in patients with AMD exudative
AMD atrophic
OTHERA blood and aqueous humor sample will be taken during cataract surgery in patients with AMD atrophic
control group
OTHERA blood and aqueous humor sample will be taken during cataract surgery in patients with cataract (control group)
Interventions
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).
Eligibility Criteria
You may qualify if:
- GENERAL CRITERIA
- Man or woman with age over 60 years,
- Patient affiliated with social security,
- Patient willing and able to return to all clinical visits to the study and complete all related procedures.
- SPECIFIC CRITERIA
- Patient who need a cataract surgery,
- Patient presenting in both eyes:
- the same type of AMD defined according to the international AREDS study modified (Ferris et al., 2013) no other ophthalmological pathology (control group).
You may not qualify if:
- GENERAL CRITERIA
- Major patient under tutorship or curatorship or unable to express consent,
- Person deprived of liberty,
- SPECIFIC CRITERIA
- Patient with chronic ophthalmic pathologies other than cataract and AMD defined in the modified international AREDS study included in the eye (Ferris et al., 2013),
- Patient who participated in a clinical trial of an experimental drug for atrophic AMD,
- Patient taking systemically drugs with immunomodulatory action: immunosuppressants, immunomodulators, chemotherapy or corticosteroids,
- Patient with systemic diseases modifying his immune status,
- Patient with a history of diabetes,
- Patient who received an anti-inflammatory eye treatment in both eyes in the 6 months preceding the surgery,
- Patient having dynamic phototherapy on the included eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital de la Croix-Rousse
Lyon, 69004, France
Related Publications (1)
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.
PMID: 38233865BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thibaud Mathis, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2018
First Posted
February 1, 2018
Study Start
November 22, 2017
Primary Completion
September 8, 2020
Study Completion
September 8, 2020
Last Updated
December 5, 2025
Record last verified: 2025-11