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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Macular Diseases
• Intervention / Treatment: Diagnostic test: Intra ocular pressure Measure

Detailed Description

In order to reduce the frequency of injections in the so-called sub-optimal patients, a "new generation" anti-VEGF will arrive on the market with higher concentrations of active ingredients with a higher injection volume of 0.07mL (marketing of Aflibercept 8mg/0.07ml in France since 01/06/2025). As IOP peaks are linked to the volume injected, the repercussions of such volumes could probably be higher and require additional procedures. In fact, 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 pressure profile after IVT of 0.07mL is not known, on experimental ocular models, the IOP after an IVT of 0.07mL could reach more than 70mmHg with a return to normal after 20 to 25 minutes. So to evaluate the IOP profile after intravitreal injection of Aflibercept 8mg/0.07mL, the IOP will be monitored after an injection during 45 minutes. IOP will be measure with a Perkins Tonometer in order to have aplanation results. Measures will be done just before and after the injection and at 15minutes, 30 minutes and 45 minutes.

To evaluate the risk of transient monocular blindness, we will note all transient blindness after the injection.

The longer-term repercussions are also not known. Indeed, the repetition of IVT leads to a repetition of IOP peaks in the same patient. The previous 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 and deserve to be researched. In order to evaluate the repercussion of the new volume, Retinal Nerve Fiber Layer assessed with Optical Coherence tomography will be done just before the injection and at the end of the follow up 12 months +/-2 months.

The treatment regimen will not be modified by the study.

The inclusion visit will be carried out during a routine care consultation. During this consultation, patients will be informed of the research and will be included once their consent has been obtained. The patient's inclusion can take place during the first IVT or during another IVT of the patient's follow-up.

During this visit, the investigator will carry out:

• A papillary OCT before IVT. This is a non-invasive light imaging technique which makes it possible to obtain cross-sectional images of the papilla and to evaluate in particular the therapeutic response to IVT,
• A first measurement of the IOP before injection (T0) by a PERKINS applanation tonometer. It uses an applanation tonometry technique, namely the measurement of IOP by counter pressure on the cornea, after the instillation of anesthetic eye drops.
• Then, injection of Aflibercept 8mg/0.07mL following the usual recommendations of the service,
• and new IOP measurements just after the injection (T1) then at 15 (T15), 30 (T30) and 45 (T45) minutes after the injection.

The consultation will therefore be extended by an additional 45 minutes compared to a traditional consultation. The application of a local anesthetic will also be added by the research to carry out IOP measurements at 30 and 45 minutes (the previous measurements, ie. T1 and T15, will benefit from the local anesthesia of the IVT carried out for current practice).

At the end of this consultation, there will be no change in patient monitoring in terms of frequency of consultations and subsequent injections. IOP measurements will only be taken during the first inclusion consultation.

Patients will perform a new papillary OCT 1 year after the injection where the IOP was monitored, i.e. 1 year after inclusion in the research.

Follow-up for research will end after the papillary OCT at 1 year.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali CESANA; Phone Number: +33 04 83 77 20 60; Email: magali.cesana@ch-toulon.fr

Study Locations

• France
  • Var
    • Toulon, Var, France, 83000
      • Recruiting
      • Military Hopsital of Sainte Anne
      • Contact: Hussam EL CHEHAB, MD, FEBO; Phone Number: +33 0483162576; Email: Hussam.el-chehab@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IOP Monitoring	Diagnostic test: Intra ocular pressure Measure; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At baseline before the intravitreal injection (T0) and 1 year
Number of patients who experienced transient monocular blindness	Evaluation the hand motion after the intravitreal injection	In the minute following 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.	At baseline : just before injection (T0), just after injection (T1) and at 15 minutes (T15), 30 minutes (T30) and 45 minutes after injection (T45)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Collaborators: Sainte-Anne Military Teaching Hospital
• Investigators: Study Director: Hussam EL CHEHAB, MD, FEBO, Military Hospital of Sainte Anne, Toulon, France

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aflibercept; Anti-VEGF; Intravitreal injection; Diabetic Macula Edema; Wet age-related macular degeneration (AMD)
• Other Study ID Numbers: 2025-CHITS-001; 2025-A00113-46 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No