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

Recruiting

• Conditions: AMD

• Registration Number: NCT05547633
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-21
• Study Start: 2023-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2027-01
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the prevalence of sinusitis in patients with bilateral multi-injected neovascular AMD (≥ 6 intravitreal injections per year in at least one eye)	Day 0	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).

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschild; 🇫🇷 Paris, France