Biomarkers and Choroidal Neovascularization (BioNéoRet)

April 23, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Ophtalmopole Hôpital Cochin
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 months
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biomarkers and treatment response
Time Frame: 24 months
Correlation between biomarker level and the response to anti-VEGF treatment
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2020

Primary Completion (Estimated)

January 6, 2027

Study Completion (Estimated)

July 6, 2027

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C18-08
  • 2018-A02099-46 (Registry Identifier: 2018-A02099-46)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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