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Bigger eye injection may raise pressure – new study checks safety

NCT ID NCT06893965

Knowledge-focused Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study tracks eye pressure in 100 people receiving a larger-volume injection of Aflibercept (0.07mL) for macular diseases like age-related macular degeneration. Researchers measure pressure right after the injection and at several time points, then check for any nerve damage in the eye after one year. The goal is to see if the larger volume causes higher or longer-lasting pressure spikes than the standard smaller injection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aflibercept 8mg/0.07mL injection
What this could lead to
If successful, this study could help doctors understand whether a larger injection volume is safe and how to manage temporary eye pressure spikes, potentially allowing fewer injections for patients.
What could go wrong
This is a small, early observational study with no control group. It only measures pressure and nerve thickness, not whether the treatment works better or worse. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration diabetic macular edema macular degeneration retinal vein occlusion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Macular diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Military Hopsital of Sainte Anne

    RECRUITING

    Toulon, Var, 83000, France

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