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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
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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