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

Not Applicable

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Procedure: Aqueous humor samples collection

• Registration Number: NCT03630562
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-15
• Study Start: 2018-11-26
• Primary Completion: 2021-01-12
• Study Completion: 2021-08-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with exudative AMD	Aqueous humor samples collection	-

Primary Outcome Measures

Name	Time	Method
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months	At Month 3

Secondary Outcome Measures

Name	Time	Method
Dose of VEGF in the aqueous humor of patients with exudative AMD	At Day 0, Month 1, Month 2, Month 3
Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMD	At Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with Snellen chart	At Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with ETDRS visual acuity chart	At Day 0, Month 1, Month 2, Month 3

Trial Locations

Locations (1)

Hôpital Pasteur 2 - Service d'Ophtalmologie; 🇫🇷 Nice, France