Biomarkers and Choroidal Neovascularization (BioNéoRet)

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

Status: Active, not recruiting

Conditions: Choroidal Neovascularization; Mineralocorticoid Excess

Treatments: Other: Blood and aqueous humor biomarker of treatment response

Study type: Observational

Funder types: Other

Identifiers

NCT04439708

C18-08

2018-A02099-46 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Group 1

Description:

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

Treatment:

Other: Blood and aqueous humor biomarker of treatment response

Group 2

Description:

Control group : patients without choroidal neovascularization

Treatment:

Other: Blood and aqueous humor biomarker of treatment response