Comparison of Cytokine Profiles in Aqueous Humor of Patients With Age Related Macular Degeneration (AMD)

NCT ID: NCT03418220

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2020-09-08

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.

Conditions

Macular Degeneration, Age-Related

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

AMD early / intermediate

A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD early / intermediate

Group Type: OTHER

blood and aqueous humor sampling

Intervention Type: OTHER

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).

AMD exudative

A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD exudative

Group Type: OTHER

blood and aqueous humor sampling

Intervention Type: OTHER

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).

AMD atrophic

A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD atrophic

Group Type: OTHER

blood and aqueous humor sampling

Intervention Type: OTHER

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).

control group

A blood and aqueous humor sample will be taken during cataract surgery in patients with cataract (control group)

Group Type: OTHER

blood and aqueous humor sampling

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • GENERAL CRITERIA
• Man or woman with age over 60 years,
• Informed, written and signed consent by the patient and the investigator (no later than the day of inclusion) and before any investigation required by the research,
• 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).

Exclusion Criteria

• • GENERAL CRITERIA
• Major patient under tutorship or curatorship or unable to express consent,
• Person deprived of liberty,
• Patient participating in an ongoing clinical trial during the inclusion visit,

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thibaud Mathis, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital de la Croix-Rousse

Lyon, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 38233865 (View on PubMed)

Other Identifiers

2017-A02365-48

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0544

Identifier Type: -

Identifier Source: org_study_id