Condition: Macular Diseases · Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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 of up to 0.07mL (marketing of Aflibercept 8mg/0.07ml in France since 01/06/2025. As IOP spikes are linked to the volume injected, the repercussions of such volumes could probably be greater and require additional actions. Indeed, currently the volumes used (0.05mL) rarely lead to complications such as transient blindness secondary to ocular hypertonia. In this case, an anterior chamber puncture may be necessary. To date, the impact on IOP of the 0.07mL injection has not yet been evaluated in the short and long term. Indeed, the repetition of IVT leads to a repetition of IOP peaks of around 5…
This description comes directly from the study's public registry record.
Magali CESANA · 04 83 77 20 60 · magali.cesana@ch-toulon.fr
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| Military Hopsital of Sainte Anne | Toulon, Var, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06893965