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

NCT06893965 | Recruiting

• 2 other identifiers: 2025-CHITS-0012025-A00113-46
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macular Diseases

Keywords

Diabetic Macula Edema; Intravitreal injection; Anti-VEGF; Aflibercept; Wet age-related macular degeneration (AMD)

Outcome Measures

Primary Outcomes (1)

• Intra Ocular Pressure

  Measurement performed with Perkins Tonometer, results in mmHg

  At baseline : just before injection (T0), just after injection (T1) and at 15 minutes (T15), 30 minutes (T30) and 45 minutes after injection (T45)

Secondary Outcomes (3)

• Retinal Nerve Fiber Layer (RNFL)

  At baseline before the intravitreal injection (T0) and 1 year

• Number of patients who experienced transient monocular blindness

  In the minute following intravitreal injection

• IOP evolution in the glaucoma patient subgroup

  At baseline : just before injection (T0), just after injection (T1) and at 15 minutes (T15), 30 minutes (T30) and 45 minutes after injection (T45)

Study Arms (1)

IOP Monitoring

OTHER

Diagnostic Test: Intra ocular pressure Measure

Interventions

Intra ocular pressure Measure DIAGNOSTIC_TEST

Measurement 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

IOP Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Sainte-Anne Military Teaching Hospital: collaborator

Study Sites (1)

Military Hopsital of Sainte Anne

Toulon, Var, 83000, France

RECRUITING

Study Officials

• Hussam EL CHEHAB, MD, FEBO

  Military Hospital of Sainte Anne, Toulon, France

  STUDY DIRECTOR

Central Study Contacts

Magali CESANA

CONTACT

04 83 77 20 60; magali.cesana@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)