Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients With Exudative AMD (SINE) (SINE)

An inflammatory component associated with AMD has been highlighted by genetic associations of predisposition to AMD, as well as by the recently demonstrated link between AMD and periodontitis.

Some patients followed at the Fondation Adolphe de Rothschild Hospital for wet AMD seemed to show an improvement of neovascular activity (less need for intravitreal injections of anti-VEGF) after treatment of their sinusitis.

The investigators would therefore like to assess the link between AMD and sinusitis, an infection close to the site of AMD.

Study Overview

• Status: Recruiting
• Conditions: AMD
• Intervention / Treatment: Other: sinusitis screening consultation

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Amelie Yavchitz; Phone Number: +33148036454; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation A. de Rothschild
    • Contact: Raphaël LEJOYEUX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients followed at The Rothschild Hospital Foundation hospital for neovascular AMD receiving at least 6 intravitreal injections/year in at least one eye over the past 2 years.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patient followed and treated for at least 2 years for bilateral neovascular form of age-related macular degeneration (AMD)
• At least one eye treated with ≥ 6 intravitreal injections during the year preceding preinclusion
• Express consent to participate in the study
• Affiliated with or beneficiary of a social security plan

Exclusion Criteria:

• Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curatorship).
• Severe myopia (> 6 diopters)
• Patient already being treated for acute or chronic sinusitis
• History of central serous chorioretinopathy or diffuse retinal epitheliopathy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the prevalence of sinusitis in patients with bilateral multi-injected neovascular AMD (≥ 6 intravitreal injections per year in at least one eye)	Percentage of patients with bilateral multiinjected neovascular AMD (≥6 intravitreal injections/year in at least one eye) with sinusitis following ENT consultation screening. Sinusitis is defined by nasofibroscopic abnormalities showing sinus pathology (inflammation, polyp, rhinorrhea) and/or scannographically confirmed sinus filling (some sinusitis is blocked and therefore not externalized).	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare, between patients screened and managed for sinusitis and those not requiring treatment for sinusitis, the evolution of the number of intravitreal injections	Comparison of the change in the number of intravitreal injections performed over a 1-year period before sinusitis screening and then over a 1-year period after completion of sinusitis treatment (for patients treated for sinusitis) or a 1-year period after the screening visit for patients not treated for sinusitis. If only one of the two eyes received 6 or more injections in the year before inclusion, the evolution of the number of injections for this eye will be considered. If both eyes received 6 or more injections in the year before inclusion, the eye with the most injections will be considered, if both eyes received the same number of injections the right eye will be considered by default.	Month 15

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Sinusitis
• Other Study ID Numbers: RLX-2022-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No