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.
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
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
Single group
Intra ocular pressure Measure
Diagnostic testMeasurement of IOP before injection (T0), just after the injection (T1) then 15 (T15), 30 (T30) and 45 (T45) minutes after the injection. Measurement are done with Perkins Tonometer
Intra Ocular Pressure
Measurement performed with Perkins Tonometer, results in mmHg
Retinal Nerve Fiber Layer (RNFL)
RNFL will be assessed using Optical Coherence Tomography (OCT) before the first injection of the study (T0) and at one year of patient follow-up (M12): measurement of the RNFL (Retinal Nerve Fiber Layer or thickness of the peripapillary nerve fibers).
Number of patients who experienced transient monocular blindness
Evaluation the hand motion after the intravitreal injection
IOP evolution in the glaucoma patient subgroup
Changes in intraocular pressure will be assessed in a specific subgroup of patients treated for glaucoma.
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead sponsor
Sainte-Anne Military Teaching Hospital
Collaborator
