Biomarkers and Choroidal Neovascularization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and aqueous humor biomarker of treatment response.
- Who it may be relevant to
- Registry conditions: Choroidal Neovascularization, Mineralocorticoid Excess. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biomarkers Analysis of Mineralocortoid Receptor Activation in the Serum and Ocular Fluid of Patients With Choroidal Neovascularization
Overview
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.
Interventions
- Other Blood and aqueous humor biomarker of treatment response
Blood analyses and aqueous humor analysis
Primary outcome measures
- biomarker analysis in blood and aqueous humor of patients with neovascularization and controls [Time frame: 24 months]
- biomarker analysis in blood and aqueous humor of patients with neovascularization and controls [Time frame: 24 months]
Secondary outcome measures (1)
- biomarkers and treatment response [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 2 centers
- Ophtalmopole Hôpital Cochin — Paris
- Hôpital Foch — Suresnes
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. PMID 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. PMID 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. PMID 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 d PMID 30664640
Identifiers
NCT: NCT04439708 · C18-08 · 2018-A02099-46