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Biomarkers and Choroidal Neovascularization (BioNéoRet)

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ClinicalTrials.gov Identifier: NCT04439708
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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Brief Summary:
The aim of the study is to find biomarkers in the blood and aqueous humor of patients with type 1 choroidal neovascularization and correlate them with the response to anti-VEGF treatment.

Condition or disease Intervention/treatment
Choroidal Neovascularization Mineralocorticoid Excess Other: Blood and aqueous humor biomarker of treatment response

Detailed Description:

Age-related macular degeneration (AMD) is the most frequent cause of blindness in industrialized countries. Multiple molecular pathways have been implicated in the pathogenesis of choroidal neovascularization (CNV). Currently, the treatment relies on neutralization of VEGF (Vascular Endothelial Growth Factor). However some patients have an incomplete response to anti-VEGF treatment. A recent study suggested the implication of the mineralocorticoid receptor pathway in the formation of CNV.

The study (of investigators) aim is to evaluate the concentation of metabolites of MR pathway in the blood and aqueous humor of patients with CNV and compared them with patients without CNV in order to increase our understanding of CNV pathogenesis and find potential biomarker of response to anti-VEGF treatment.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Biomarkers Analysis of Mineralocortoid Receptor Activation in the Serum and Ocular Fluid of Patients With Choroidal Neovascularization
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
Patients with choroidal neovascularization in the context of age-related macular degeneration or central serous chorioretinopathy
 Other: Blood and aqueous humor biomarker of treatment response
Blood analyses and aqueous humor analysis
Group 2
Control group : patients without choroidal neovascularization
 Other: Blood and aqueous humor biomarker of treatment response
Blood analyses and aqueous humor analysis


Outcome Measures
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Primary Outcome Measures :
  1. biomarker analysis in blood and aqueous humor of patients with neovascularization and controls [ Time Frame: 24 months ]
    Biomarker concentrations (pg/ml) will be evaluated with ELISA (Enzyme Linked ImmunoSorbent Assay).

  2. biomarker analysis in blood and aqueous humor of patients with neovascularization and controls [ Time Frame: 24 months ]
    Biomarker concentrations (pg/ml) will be evaluated with Mulitplex Biorad.


Secondary Outcome Measures :
  1. biomarkers and treatment response [ Time Frame: 24 months ]
    Correlation between biomarker level and the response to anti-VEGF treatment


Biospecimen Retention:   Samples Without DNA
blood and aqueous humor samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Group 1 : patients with type 1 choroidal neovascularization Group 2: patients without choroidal neovascularization before ocular surgery
Criteria

Inclusion Criteria:

Patients of group 1:

  • Patients with type 1 choroidal neovascularization in a context of central serous chorioretinoathy or age related macular degeneration
  • Patients without intravitreal injection or last intravitreal injection > 3 months
  • Informed signed consent

Patients of group 2:

  • Patients without choroidal neovascularization
  • Patients with intraocular surgery (cataract or vitrectomy surgery)
  • Signed consent

Exclusion Criteria:

  • Myocardial infarction < 12 months
  • Chronic renal failure
  • Inflammatory disease
  • Infectious disease :HIV, viral hepatitis, tuberculosis
  • Type 1 or 2 Diabetes
  • Patients treated by mineralocorticoid antagonist treatment.
  • Type 2 or 3 choroidal neovascularization
  • Pregnant woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439708


Contacts
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Contact: Francine Behar-Cohen, Dr 01 44 27 81 64 francine.cohen@aphp.fr

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
More Information
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Publications:

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04439708    
Other Study ID Numbers: C18-08
2018-A02099-46 ( Registry Identifier: 2018-A02099-46 )
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
central serous chorioretinopathy
age related macular degeneration
biomarker
Additional relevant MeSH terms:
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Choroidal Neovascularization
Hyperaldosteronism
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Choroid Diseases
 Uveal Diseases
Eye Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases