Biomarkers and Choroidal Neovascularization

Choroidal Neovascularization Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04439708
• Other study ID #: C18-08
• Secondary ID: 2018-A02099-46
• Status: Not yet recruiting
• Start date: June 15, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2020
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Francine Behar-Cohen, Dr
• Phone: 01 44 27 81 64
• Email: francine.cohen[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Hyperaldosteronism
• Mineralocorticoid Excess
• Neovascularization, Pathologic

Intervention

Other:
• Blood and aqueous humor biomarker of treatment response
Blood analyses and aqueous humor analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (4)

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. Review. — View Citation

Rezar-Dreindl S, Sacu S, Eibenberger K, Pollreisz A, Bühl 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 months
Primary	biomarker analysis in blood and aqueous humor of patients with neovascularization and controls	Biomarker concentrations (pg/ml) will be evaluated with Mulitplex Biorad.	24 months
Secondary	biomarkers and treatment response	Correlation between biomarker level and the response to anti-VEGF treatment	24 months