Actively Recruiting

Phase Not Applicable
Age: 15Years +
All Genders
NCT04697095

Survival of Monocytes Collected From Patients With Atrophic AMD in Retinal Pigmented Epithelium Explants

Led by Hospices Civils de Lyon · Updated on 2025-03-07

80

Participants Needed

2

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Age-related macular degeneration (AMD) affects 2 million people in France and is the main cause of irreversible blindness in France. All patients initially have an early form of the disease. This early form can evolve in two different ways: the atrophic form, which progresses slowly, and the exudative or neovascular form, which has a more rapid evolution. While there are treatments for the exudative form of the disease, there is currently no therapy for the atrophic form of AMD. Recently, it has been demonstrated in atrophic AMD that there is accumulation of inflammatory cells, monocytes, in the sub-retinal space. This space is located between the retinal pigment epithelium (RPE) and photoreceptors. It is physiologically devoid of immune cells (immune privilege). Monocytes secrete many pro-inflammatory molecules, such as cytokines. Some cytokines (IL-1, IL6 and TNF) have a deleterious role on RPE and photoreceptors in mouse models. The identification of specific cytokines would help to better understand this disease and consider potential targeted therapies. Our project is based on the hypothesis that monocytes extracted from patients with AMD have a superior survival on RPE compared to monocytes extracted from healthy patients (without retinal pathology), and more particularly in atrophic forms of AMD. The main aim of this study is to compare the survival of monocytes extracted from patients with atrophic AMD to monocytes extracted from patients without retinal pathology (control) on retinal pigment epithelial cell lines (ARPE-19). Survival will be evaluated by automated counting of monocytes after 24 hours of culture on ARPE-19 after specific immunostaining of monocytes. If the survival of monocytes from patients with the late form of AMD is increased then therapy directly targeting this pathological accumulation of monocytes could be considered. Moreover, the identification of increased secretion of certain cytokines and the demonstration of their deleterious effect on retinal physiology could lead to targeted therapies against them.

CONDITIONS

Official Title

Survival of Monocytes Collected From Patients With Atrophic AMD in Retinal Pigmented Epithelium Explants

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female older than 50
  • Provide written informed consent
  • Patient affiliated to French social security
  • Maximum sampling volume per 30-day period adapted to patient weight
  • Patient with either the same type of AMD in both eyes as defined by the modified international AREDS study
  • Patient with early AMD in one eye and atrophic AMD in the other, defined as atrophic
  • Patient with early AMD in one eye and exudative AMD in the other, defined as exudative
  • Patient with no retinal pathology (control group)
Not Eligible

You will not qualify if you...

  • Patient weighing less than 50 kg
  • Adult under guardianship, curatorship, or unable to consent
  • Person deprived of liberty
  • Participating in another ongoing clinical trial during inclusion
  • Patient with atrophic AMD in one eye and exudative AMD in the other eye
  • Chronic retinal diseases other than AMD in the included eye
  • Taking systemic immunomodulatory drugs such as immunosuppressants, immunomodulators, chemotherapy, or corticosteroids
  • Having systemic diseases affecting immune status
  • History of diabetes
  • History of dynamic phototherapy on the included eye

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hôpital Edouard Herriot

Lyon, France, 69003

Actively Recruiting

2

Service d'ophtalmologie-HOSPICES CIVILS DE LYON - Hôpital de la Croix-Rousse

Lyon, France, 69004

Actively Recruiting

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Research Team

T

Thibaud Mathis, MD

CONTACT

C

Christelle Szatanek

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

4

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Survival of Monocytes Collected From Patients With Atrophic AMD in Retinal Pigmented Epithelium Explants | DecenTrialz