Biomarkers and Choroidal Neovascularization

NCT04439708 | Active Not Recruiting

• 2 other identifiers: C18-082018-A02099-46
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Choroidal Neovascularization; Mineralocorticoid Excess

Keywords

central serous chorioretinopathy; age related macular degeneration; biomarker

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• biomarkers and treatment response

  24 months

Study Arms (2)

Group 1

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

Other: Blood and aqueous humor biomarker of treatment response

Group 2

Control group : patients without choroidal neovascularization

Other: Blood and aqueous humor biomarker of treatment response

Interventions

Blood and aqueous humor biomarker of treatment response OTHER

Blood analyses and aqueous humor analysis

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1 : patients with type 1 choroidal neovascularization Group 2: patients without choroidal neovascularization before ocular surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (2)

Ophtalmopole Hôpital Cochin

Paris, 75014, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30664640 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and aqueous humor samples

MeSH Terms

Conditions

Choroidal Neovascularization; Hyperaldosteronism; Central Serous Chorioretinopathy; Macular Degeneration

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Retinal Diseases; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: June 19, 2020
• Study Start: July 6, 2020
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

FR (2)