Biomarkers and Choroidal Neovascularization

NCT ID: NCT04439708

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2027-07-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Choroidal Neovascularization Mineralocorticoid Excess

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients with choroidal neovascularization in the context of age-related macular degeneration or central serous chorioretinopathy

Blood and aqueous humor biomarker of treatment response

Intervention Type OTHER

Blood analyses and aqueous humor analysis

Group 2

Control group : patients without choroidal neovascularization

Blood and aqueous humor biomarker of treatment response

Intervention Type OTHER

Blood analyses and aqueous humor analysis

Interventions

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Blood and aqueous humor biomarker of treatment response

Blood analyses and aqueous humor analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ophtalmopole Hôpital Cochin

Paris, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 24711658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28522341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27537264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30664640 (View on PubMed)

Other Identifiers

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2018-A02099-46

Identifier Type: REGISTRY

Identifier Source: secondary_id

C18-08

Identifier Type: -

Identifier Source: org_study_id

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