Biomarkers and Choroidal Neovascularization (NCT04439708) | Clinical Trial Compass
RecruitingNot Applicable
Biomarkers and Choroidal Neovascularization
France250 participantsStarted 2020-07-06
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at biomarkers in both blood and a fluid from inside the eye called aqueous humor — does collecting aqueous humor involve any risk to my vision or eye health that I should weigh before considering participation?
2The trial is studying a possible connection between mineralocorticoid excess and choroidal neovascularization — could my doctor explain what mineralocorticoids are and whether my specific case shows any signs that this pathway might be involved?
3Since this is listed as a non-interventional biomarker study rather than a treatment trial, does participating mean I would still receive my standard treatment for choroidal neovascularization, or could enrollment affect my care in any way?
4This study compares patients with neovascularization to controls — does my doctor think my current diagnosis and health history would make me a reasonable candidate to discuss with the research team, or are there features of my case that might not fit what they're looking for?
5If the biomarkers being studied here do turn out to be meaningful, could my doctor explain how that kind of research might eventually affect treatment decisions for conditions like mine, and whether there are already any treatment implications related to the mineralocorticoid pathway?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
biomarker analysis in blood and aqueous humor of patients with neovascularization and controls
Timeframe: 24 months
2
biomarker analysis in blood and aqueous humor of patients with neovascularization and controls
Timeframe: 24 months
Trial details
NCT IDNCT04439708
SponsorInstitut National de la Santé Et de la Recherche Médicale, France