Clinical trial NCT04439708: Biomarkers and Choroidal Neovascularization
Official title: Biomarkers Analysis of Mineralocortoid Receptor Activation in the Serum and Ocular Fluid of Patients With Choroidal Neovascularization
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Choroidal Neovascularization
Mineralocorticoid Excess
Keywords: central serous chorioretinopathy
age related macular degeneration
biomarker
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2020-06-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1 : patients with type 1 choroidal neovascularization Group 2: patients without choroidal neovascularization before ocular surgery

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.

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.

Eligibility 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

Primary outcomes:
measure: biomarker analysis in blood and aqueous humor of patients with neovascularization and controls
timeFrame: 24 months
measure: biomarker analysis in blood and aqueous humor of patients with neovascularization and controls
timeFrame: 24 months
Secondary outcomes:
measure: biomarkers and treatment response
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Ophtalmopole Hôpital Cochin
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.