Actively Recruiting
Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients With Exudative AMD (SINE)
Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-12-10
200
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the connection between age-related macular degeneration (AMD), specifically the wet or neovascular form, and sinusitis, an infection near the eye area. This study aims to assess whether treating sinusitis could influence the activity of AMD, given early observations that some patients showed less need for eye injections after sinusitis treatment. The study is observational and conducted at a single center to better understand this possible link. Participants will undergo a sinusitis screening consultation involving questions about symptoms like nasal discharge, congestion, smell issues, and facial pain, along with a clinical examination that includes nasofibroscopy. Those showing signs of sinusitis will receive management based on current medical guidelines, which may include imaging, medication, or surgery if needed. The study focuses on patients who have been treated for bilateral neovascular AMD with multiple intravitreal injections. During the study, participants will be assessed for the prevalence of sinusitis and its impact on their need for eye injections. The main outcome is to estimate how common sinusitis is among these patients at the start of the study. Secondary outcomes include comparing injection frequency over 15 months between those treated for sinusitis and those not requiring treatment. Participants will be monitored regularly, with consent and social security coverage required for participation.
CONDITIONS
Brief Title
Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients With Exudative AMD (SINE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient treated for at least 2 years for bilateral neovascular age-related macular degeneration
- At least one eye treated with 6 or more intravitreal injections in the year before preinclusion
- Express consent to participate in the study
- Affiliated with or beneficiary of a social security plan
You will not qualify if you...
- Protected persons including pregnant women, nursing mothers, persons deprived of liberty, minors, and those under legal protection
- Severe myopia greater than 6 diopters
- Already being treated for acute or chronic sinusitis
- History of central serous chorioretinopathy or diffuse retinal epitheliopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a sinusitis screening consultation involving questioning and clinical examination including nasofibroscopy. Those with signs of sinusitis may receive further diagnostic imaging tests and management according to current recommendations.
1 visit (in-person)
Duration - 15 months
Participants are observed over time to compare the evolution of the number of intravitreal injections between those managed for sinusitis and those not requiring treatment.
Visits as per usual care; no additional trial visits required
Trial Site Locations
Total: 1 location
1
Hôpital Fondation A. de Rothschild
Paris, France, 75019
Actively Recruiting
Research Team
A
Amélie Yavchitz
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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