Clinical trial NCT03418220: Comparison of Cytokine Profiles in Aqueous Humor of Patients With Age Related Macular Degeneration (AMD)
Official title: Comparison of Cytokine Profiles in Aqueous Humor of Patients With Age Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration, Age-Related
Keywords: Age related Macular Degeneration
Atrophy
Inflammation
Cytokines
test LUMINEX®
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Comparison of concentrations of intraocular inflammation markers between the group of patients with atrophic AMD and the control group.
timeFrame: day of surgery
Secondary outcomes:
measure: Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] between the group of patients with atrophic AMD and the control group.
timeFrame: day of surgery
measure: Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] between the different stages of AMD: early / intermediate, exudative or atrophic
timeFrame: day of surgery
measure: 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)
timeFrame: day of surgery
measure: Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] according to the macular atrophy area measured by autofluorescence in atrophic AMD.
timeFrame: day of surgery
measure: 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
timeFrame: day of surgery
measure: Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] according to the recognized risk factors of AMD
timeFrame: day of surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Thibaud Mathis, MD
role: PRINCIPAL_INVESTIGATOR
References: