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RecruitingNCT04439708BioNéoRetUpdated Jul 7, 2026

Biomarkers and Choroidal Neovascularization

An observational study in Choroidal Neovascularization and Mineralocorticoid Excess, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Recruiting at 2 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Choroidal Neovascularization
  • Mineralocorticoid Excess

Keywords

  • central serous chorioretinopathy
  • age related macular degeneration
  • biomarker
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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

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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Group 2

    Control group : patients without choroidal neovascularization

    Other: Blood and aqueous humor biomarker of treatment response

Interventions

  • OtherBlood and aqueous humor biomarker of treatment response

    Blood analyses and aqueous humor analysis

05

What researchers measure

Primary outcomes

  1. biomarker analysis in blood and aqueous humor of patients with neovascularization and controls

    Biomarker concentrations (pg/ml) will be evaluated with ELISA (Enzyme Linked ImmunoSorbent Assay).

    Time frame: 24 months

  2. biomarker analysis in blood and aqueous humor of patients with neovascularization and controls

    Biomarker concentrations (pg/ml) will be evaluated with Mulitplex Biorad.

    Time frame: 24 months

Secondary outcomes

  1. biomarkers and treatment response

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

    Time frame: 24 months

06

Study locations

2 of 2 sites recruiting
  • Ophtalmopole Hôpital Cochin
    Paris, 75014, France
    Recruiting
  • Hôpital Foch
    Suresnes, 92150, France
    Recruiting
07

References and documents

Publications

  • Suzuki M, Nagai N, Izumi-Nagai K, Shinoda H, Koto T, Uchida A, Mochimaru H, Yuki K, Sasaki M, Tsubota K, Ozawa Y. Predictive factors for non-response to intravitreal ranibizumab treatment in age-related macular degeneration. Br J Ophthalmol. 2014 Sep;98(9):1186-91. doi: 10.1136/bjophthalmol-2013-304670. Epub 2014 Apr 7. PubMed 24711658 ↗
  • Kersten E, Paun CC, Schellevis RL, Hoyng CB, Delcourt C, Lengyel I, Peto T, Ueffing M, Klaver CCW, Dammeier S, den Hollander AI, de Jong EK. Systemic and ocular fluid compounds as potential biomarkers in age-related macular degeneration. Surv Ophthalmol. 2018 Jan-Feb;63(1):9-39. doi: 10.1016/j.survophthal.2017.05.003. Epub 2017 May 15. PubMed 28522341 ↗
  • Rezar-Dreindl S, Sacu S, Eibenberger K, Pollreisz A, Buhl W, Georgopoulos M, Krall C, Weigert G, Schmidt-Erfurth U. The Intraocular Cytokine Profile and Therapeutic Response in Persistent Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2016 Aug 1;57(10):4144-50. doi: 10.1167/iovs.16-19772. PubMed 27537264 ↗
  • Zhao M, Mantel I, Gelize E, Li X, Xie X, Arboleda A, Seminel M, Levy-Boukris R, Dernigoghossian M, Prunotto A, Andrieu-Soler C, Rivolta C, Canonica J, Naud MC, Lechner S, Farman N, Bravo-Osuna I, Herrero-Vanrell R, Jaisser F, Behar-Cohen F. Mineralocorticoid receptor antagonism limits experimental choroidal neovascularization and structural changes associated with neovascular age-related macular degeneration. Nat Commun. 2019 Jan 21;10(1):369. doi: 10.1038/s41467-018-08125-6. PubMed 30664640 ↗
08

Registry details

Key details

Study ID
NCT04439708
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Jun 19, 2020
Start date
Jul 6, 2020
Primary completion
Jan 6, 2027 (estimated)
Completion
Jul 6, 2027 (estimated)
Last update
Jul 7, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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