Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

NCT ID: NCT03630562

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2021-08-19

Brief Summary

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Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines.

The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.

Detailed Description

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Conditions

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Age Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with exudative AMD

Group Type OTHER

Aqueous humor samples collection

Intervention Type PROCEDURE

In addition to the routine examinations performed as part of the usual care of AMD patients, an anterior chamber puncture will be performed to collect the aqueous humor samples.

Interventions

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Aqueous humor samples collection

In addition to the routine examinations performed as part of the usual care of AMD patients, an anterior chamber puncture will be performed to collect the aqueous humor samples.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Diagnosis of exudative age-related macular degeneration requiring intravitreal anti-VEGF treatment.
* Patient for whom the last intravitreal injection of anti-VEGF in the eye is strictly more than 3 months
* Signature of informed consent
* Affiliation to the French social security system

Exclusion Criteria

* Pregnant or nursing patient (a urinary pregnancy test will be performed)
* Systemic treatment with anti-VEGF
* Intravitreal treatment with anti-VEGF for less than 3 months regardless of the treated eye.
* Retinal pathology that can modify the secretion of pro-inflammatory cytokines such as diabetic retinopathy, venous occlusions, intermediate and posterior uveitis.
* Diabetes Mellitus
* High Myopia
* Simultaneous participation in another clinical research protocol in exudative AMD
* Person under guardianship, under curatorship, deprived of liberty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Stéphanie BAILLIF, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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Hôpital Pasteur 2 - Service d'Ophtalmologie

Nice, , France

Site Status

Countries

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France

Other Identifiers

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17-PP-18

Identifier Type: -

Identifier Source: org_study_id

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