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

November 28, 2025 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hôpital de la Croix-Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: AMD early / intermediate
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD early / intermediate
Other: 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).
Other: AMD exudative
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD exudative
Other: 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).
Other: AMD atrophic
A blood and aqueous humor sample will be taken during cataract surgery in patients with AMD atrophic
Other: 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).
Other: control group
A blood and aqueous humor sample will be taken during cataract surgery in patients with cataract (control group)
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of concentrations of intraocular inflammation markers between the group of patients with atrophic AMD and the control group.
Time Frame: day of surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] between the group of patients with atrophic AMD and the control group.
Time Frame: day of surgery

Aqueous humor sample and the blood 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 inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y).

For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated.

Each ratio will be compared between patients with atrophic AMD and patients of 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
Time Frame: day of surgery

Aqueous humor sample and the blood sample will be collected during the cataract surgery in patient with different stage of AMD : early / intermediate, exudative or atrophic.

In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated and compared between 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)
Time Frame: day of surgery
Autofluorescence exam allows in vivo mapping of lipofuscin distribution. Lipofuscin is a fluorophore of the retinal pigment epithelium. Autofluorescence represents in gray scale the spatial distribution of lipofuscin, and reflect the metabolic activity of the retinal pigment epithelium. Autofluorescence exam allows classification in different types of atrophic AMD. Autofluorescence exam was performed for all patients at the first visit. Aqueous humor sample and blood sample will be collected during the cataract surgery. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated, and compared between the different types of atrophic AMD.
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.
Time Frame: day of surgery
Macular atrophy area is measured at first visit in autofluorescent exam. Aqueous humor sample and the blood sample will be collected during the cataract surgery. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated, and compared between the different size of macular atrophy area.
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
Time Frame: day of surgery
OCT define precisely the retinal structures and their locations. Aqueous humor sample and the blood sample will be collected during the cataract surgery. In order to identify and quantify inflammation markers, LUMINEX® Multiplex analysis of the samples will be done by the Bio-Plex Pro Human Cytokine 27-Plex Panel (Bio-Rad, M500KCAF0Y). For each identified intraocular inflammatory marker, the ratio between the level of expression in the aqueous humor sample and the level of expression in the blood sample will be calculated, and compared between the different thickness of retina measured by OCT .
day of surgery
Comparison of the concentration ratios of inflammation marker [aqueous humor / blood] according to the recognized risk factors of AMD
Time Frame: day of surgery
ratios of [aqueous humor / blood] concentrations of inflammation markers will be compared on age, female sex, smoking (number of pack-years), obesity (body mass index)
day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thibaud Mathis, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0544
  • 2017-A02365-48 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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