Choroidal NeovascularizationBioNéoRetNCT04439708
Biomarkers and Choroidal Neovascularization
An observational study of Choroidal Neovascularization and Mineralocorticoid Excess, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Choroidal Neovascularization, Mineralocorticoid Excess
- What is being tested?
- Blood and aqueous humor biomarker of treatment response
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jul 2020to 6 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group 1 : patients with type 1 choroidal neovascularization Group 2: patients without choroidal neovascularization before ocular surgery
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Ophtalmopole Hôpital Cochin
Paris, 75014
Francine Pr. Behar-Cohen, +33660974419, Francine.cohen@aphp.fr
- Recruiting
Hôpital Foch
Suresnes, 92150
Vincent Pierre-Khan, +331462275, pkahnv@gmail.com
About this study
Official title: Biomarkers Analysis of Mineralocortoid Receptor Activation in the Serum and Ocular Fluid of Patients With Choroidal Neovascularization
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.
Read the 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.
- Being tested
- Blood and aqueous humor biomarker of treatment response
- Keywords
- central serous chorioretinopathy, age related macular degeneration, biomarker
- Medical subject headings
- Choroidal Neovascularization, Hyperaldosteronism, Central Serous Chorioretinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and aqueous humor biomarker of treatment responseOther
Blood analyses and aqueous humor analysis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with choroidal neovascularization in the context of age-related macular degeneration or central serous chorioretinopathy Receives: Other: Blood and aqueous humor biomarker of treatment response | |
| Group 2 | Control group : patients without choroidal neovascularization Receives: Other: Blood and aqueous humor biomarker of treatment response |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
biomarker analysis in blood and aqueous humor of patients with neovascularization and controls
Biomarker concentrations (pg/ml) will be evaluated with Mulitplex Biorad.
Measured: 24 months
Secondary outcomes (1)
biomarkers and treatment response
Correlation between biomarker level and the response to anti-VEGF treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start6 Jul 2020
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Choroidal NeovascularizationStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439708
- Sponsor's protocol ID
- C18-08
- Other IDs
- 2018-A02099-46
- Acronym
- BioNéoRet
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24711658Kersten 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.
PubMed 28522341Rezar-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.
PubMed 27537264Zhao 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.
PubMed 30664640
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Analysis of Mineralocortoid Receptor Activation in the Serum and Ocular Fluid of Patients With Choroidal Neovascularization
- ClinicalTrials.gov ID
- NCT04439708
- Acronym / sponsor ID
- BioNéoRet / C18-08
- Keywords
- central serous chorioretinopathy, age related macular degeneration, biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Blood and aqueous humor biomarker of treatment responsePatients with choroidal neovascularization in the context of age-related macular degeneration or central serous chorioretinopathy |
| Group 2 | – | Other: Blood and aqueous humor biomarker of treatment responseControl group : patients without choroidal neovascularization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 : patients with type 1 choroidal neovascularization Group 2: patients without choroidal neovascularization before ocular surgery
Key inclusion criteria (8 listed)
- 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 without choroidal neovascularization
- Patients with intraocular surgery (cataract or vitrectomy surgery)
Key exclusion criteria (8 listed)
- Myocardial infarction < 12 months
- Chronic renal failure
- Inflammatory disease
- Infectious disease :HIV, viral hepatitis, tuberculosis
- Type 1 or 2 Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and aqueous humor biomarker of treatment responseBlood analyses and aqueous humor analysis | Other | Group 1, Group 2 |
Primary outcome
biomarker analysis in blood and aqueous humor of patients with neovascularization and controls
Time frame: 24 months
Biomarker concentrations (pg/ml) will be evaluated with ELISA (Enzyme Linked ImmunoSorbent Assay).
biomarker analysis in blood and aqueous humor of patients with neovascularization and controls
Time frame: 24 months
Biomarker concentrations (pg/ml) will be evaluated with Mulitplex Biorad.
1 secondary outcome
biomarkers and treatment response
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 24711658Suzuki 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.
- Background: PubMed 28522341Kersten 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.
- Background: PubMed 27537264Rezar-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.
- Background: PubMed 30664640Zhao 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.
Related trials for Choroidal Neovascularization
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Neovascularization and Mineralocorticoid Excess, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francine Behar-Cohen, Dr (01 44 27 81 64, francine.cohen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarker analysis in blood and aqueous humor of patients with neovascularization and controls (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439708, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.