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NCT Number: NCT04439708

Biomarkers and Choroidal Neovascularization

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.

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Key information

Conditions

Choroidal Neovascularization Adrenal Gland Diseases Adrenocortical Hyperfunction Central Serous Chorioretinopathy Choroid Diseases Endocrine System Diseases Eye Diseases Hyperaldosteronism Macular Degeneration Metaplasia Mineralocorticoid Excess Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophtalmopole Hôpital Cochin, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and aqueous humor biomarker of treatment response

Other

Blood analyses and aqueous humor analysis

Primary outcomes

  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 outcomes

  1. biomarkers and treatment response

    Time frame: 24 months

    Correlation between biomarker level and the response to anti-VEGF treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Francine Behar-Cohen, Dr

CONTACT

[email protected]

01 44 27 81 64

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Biomarkers Analysis of Mineralocortoid Receptor Activation in the Serum and Ocular Fluid of Patients With Choroidal Neovascularization

Acronym: BioNéoRet

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 19, 2020
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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