Eye pressure monitoring after Aflibercept 8 mg (0.07 mL) injection
Official title: Intra Ocular Pressure Monitoring After Intravitreal Injection of Aflibercept 8mg/0.07mL
Run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · NCT06893965 · Data updated 2026-11-12
This will test how eye pressure changes in adults receiving an Aflibercept 8 mg (0.07 mL) intravitreal injection for macular disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Academic / other |
| Locations | 1 site (Toulon, Var) |
| Status | Recruiting |
| Started | July 8, 2025 |
| Main results expected | July 2028 |
| Study ends | July 2029 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT06893965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with an indication for Aflibercept 8 mg (0.07 mL), including treatment-naïve or switched (suboptimal responder) patients who can give informed consent and have social security coverage, are eligible.
✕Probably not a fit
Pregnant or breastfeeding women, patients under legal protection, people with significant astigmatism that distorts applanation IOP readings, and those not receiving Aflibercept injections are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol measures intraocular pressure (IOP) before and after a single intravitreal Aflibercept 8 mg (0.07 mL) injection using a Perkins applanation tonometer. IOP will be recorded immediately before and after the injection and at 15, 30, and 45 minutes to capture short-term pressure spikes. The team will note any episodes of transient monocular blindness and any emergency procedures required, such as anterior chamber puncture. Participants include adults with macular disease who are either treatment-naïve or switched to Aflibercept for suboptimal response.
Why it matters
Potential benefit: If successful, the results could clarify whether the larger 0.07 mL Aflibercept injections cause higher short-term IOP spikes and help guide safer monitoring and emergency management to reduce vision risks.
How similar studies have gone: Prior reports with the standard 0.05 mL intravitreal injections have documented brief IOP spikes and rare complications, but the pressure profile after 0.07 mL injections in humans has not previously been characterized.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Military Hopsital of Sainte Anne
Toulon, Var, France Recruiting
Study contacts
- Study coordinator: Magali CESANA
- Email: magali.cesana@ch-toulon.fr
- Phone: 04 83 77 20 60
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.