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

Study acronym: AFLIPIO
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv8
  2. Notable Primary completion pushed from Jul 2026 to Jul 2028
    • Study completion pushed from Jul 2027 to Jul 2029
    v7
  3. Minor 2 versions Re-verified since Mar 17, 2026, no change to tracked fieldsv5-v6
  4. Minor Collaborator revisedv4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Apr 2026 to Jul 2026
    • Study completion date: Apr 2027 to Jul 2027
    • Start date changed from estimate of Apr 2025 to Jul 8, 2025
    • Site details revised
    • Collaborator revised
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06893965
Lead Sponsor Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: Sainte-Anne Military Teaching Hospital
Conditions
(from sponsor)
Macular Diseases
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov