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

NCT05547633 | Recruiting

• 1 other identifier: RLX-2022-4
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To compare, between patients screened and managed for sinusitis and those not requiring treatment for sinusitis, the evolution of the number of intravitreal injections

  Month 15

Interventions

sinusitis screening consultation OTHER

Questioning to look for suspicious anamnestic elements such as rhinorrhea, nasal obstruction, smell disorders, facial pain and clinical examination including nasofibroscopy. Patients with signs of sinusitis will be managed according to current recommendations (diagnostic imaging tests, medical treatment or even surgery if necessary).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

RECRUITING

Central Study Contacts

Amélie Yavchitz

CONTACT

+33148036454; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: January 20, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)