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Acute Intra Ocular Pressure Monitoring After Aflibercept 8mg/0.07mL

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Intercommunal de Toulon La Sey…
NCT06893965 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In just a few years, intravitreal injections have become a standard method of administration for certain retinal deseases (age-related macular degeneration \[AMD\], diabetic edematous maculopathy or retinal vein occlusion \[RVO\]). Thus, vascular endothelial growth factor (anti-VEGF) inhibitors are injected repetitively, every 4 to 6 weeks, in some patients in order to treat such pathologies. It is established that each of these IVTs has repercussions on the intraocular pressure (IOP) of patients. They immediately present with an intraocular pressure spike (IOP reaching nearly 50mmHg) for a duration of a few minutes (between 15 and 30 minutes) when the injected volume is 0.05mL, which is currently used. In order to reduce the frequency of injections in patients, higher concentrations of active ingredients with anti-VEGF properties will arrive on the market with higher injection volumes

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient aged 18 or over; * Patient with an indication for Aflibercept 8mg/0.07mL (EYLEA 8mg) * Naive or switched patient, i.e. so-called suboptimal responder to anti-VEGF with high injection frequencies * Patient with rights to social security * Having given free and informed consent before any participation in research. Exclusion Criteria: * Pregnant or breastfeeding woman * Patient under legal protection (guardianship, curatorship, etc.) or legal protection * Patient with significant astigmatism distorting the IOP values in applanation * Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the study objectives
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What it tests

  • Intra ocular pressure Measure
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Where

1 site
Military Hopsital of Sainte Anne
Toulon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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