Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients With Exudative AMD (SINE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sinusitis screening consultation.
- Who it may be relevant to
- Registry conditions: AMD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other sinusitis screening consultation
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).
Primary outcome measures
- Estimate the prevalence of sinusitis in patients with bilateral multi-injected neovascular AMD (≥ 6 intravitreal injections per year in at least one eye) [Time frame: Day 0]
Secondary outcome measures (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 [Time frame: Month 15]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Fondation A. de Rothschild — Paris
Identifiers
NCT: NCT05547633 · RLX-2022-4