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NCT Number: NCT05547633

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

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Key information

Conditions

AMD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location status: Recruiting

Location contact

Raphaël LEJOYEUX

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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)

    Time frame: 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 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie Yavchitz

CONTACT

[email protected]

+33148036454

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: SINE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 21, 2022
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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