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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2020

Interventions

  • Procedure: 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.

Arms, Groups and Cohorts

  • Other: Patients with exudative AMD

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nice
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Prof. St├ęphanie BAILLIF, MD, PhD, Principal Investigator, Centre Hospitalier Universitaire de Nice
  • Overall Contact(s)
    • Prof. St├ęphanie BAILLIF, MD, PhD, +33 (0)4.92.03.80.25, baillif.s@chu-nice.fr

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