Intra Ocular Pressure Monitoring After Intravitreal Injection of Aflibercept 8mg/0.07mL

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 50mmHg in the same patient. Some studies have analyzed the anatomical repercussions on the optic nerve of these peaks and have noted a reduction in the thickness of the peripapillary nerve fibers (RNFL for Retinal Nerve Fiber Layer) in Optical Coherence Tomography (OCT for Optical Coherence Tomography) after the 3 monthly IVTs recommended for the induction phase of treatment. But other studies have not found a significant drop in RNFL after several years of regular treatment with IVT. The studies were all carried out with volumes of 0.05mL and the repercussions with a volume of 0.07mL are therefore not reported in the literature. The AFLIPIO study aims to study the short-term pressure profile after performing an IVT of Aflibercept, at a volume of 0.07mL, and to evaluate the longer-term anatomical repercussions (12 months) on the head of the optic nerve when repeating IVT of Aflibercept, at a volume of 0.07mL.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Military Hopsital of Sainte Anne
RECRUITING
Toulon
Contact Information
Primary
Magali CESANA
magali.cesana@ch-toulon.fr
04 83 77 20 60
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2027-07
Participants
Target number of participants: 100
Treatments
Other: IOP Monitoring
Sponsors
Leads: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: Hôpital d'instruction des armées Sainte-Anne

This content was sourced from clinicaltrials.gov