Macular DiseasesAFLIPIONCT06893965
Acute Intra Ocular Pressure Monitoring After Aflibercept 8mg/0.07mL
A study testing Intra ocular pressure Measure in people with Macular Diseases, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial 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]). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Diseases
- What is being tested?
- Intra ocular pressure Measure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Military Hopsital of Sainte Anne
Toulon, Var, 83000
Hussam EL CHEHAB, MD, FEBO, 0483162576 ext. +33, Hussam.el-chehab@intradef.gouv.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Macular Diseases
- Being tested
- Intra ocular pressure Measure
- Keywords
- Diabetic Macula Edema, Intravitreal injection, Anti-VEGF, Aflibercept, Wet age-related macular degeneration (AMD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra ocular pressure MeasureDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| IOP Monitoring | Other | Not described Receives: Diagnostic Test: Intra ocular pressure Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Ocular Pressure
Measurement performed with Perkins Tonometer, results in mmHg
Measured: 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)
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).
Measured: 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
Measured: 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.
Measured: At baseline : just before injection (T0), just after injection (T1) and at 15 minutes (T15), 30 minutes (T30) and 45 minutes after injection (T45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start8 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Sainte-Anne Military Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Hussam EL CHEHAB, MD, FEBO, Study director, Sainte-Anne Military Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893965
- Sponsor's protocol ID
- 2025-CHITS-001
- Other IDs
- 2025-A00113-46
- Acronym
- AFLIPIO
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Ocular Pressure Monitoring After Intravitreal Injection of Aflibercept 8mg/0.07mL
- ClinicalTrials.gov ID
- NCT06893965
- Acronym / sponsor ID
- AFLIPIO / 2025-CHITS-001
- Conditions
- Macular Diseases
- Keywords
- Diabetic Macula Edema, Intravitreal injection, Anti-VEGF, Aflibercept, Wet age-related macular degeneration (AMD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Sainte-Anne Military Teaching Hospital
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOP Monitoring | Other | Diagnostic Test: Intra ocular pressure Measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra ocular pressure MeasureMeasurement 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 | Diagnostic test | IOP Monitoring |
Primary outcome
Intra Ocular Pressure
Time frame: At baseline : just before injection (T0), just after injection (T1) and at 15 minutes (T15), 30 minutes (T30) and 45 minutes after injection (T45)
Measurement performed with Perkins Tonometer, results in mmHg
3 secondary outcomes
Retinal Nerve Fiber Layer (RNFL)
Time frame: At baseline before the intravitreal injection (T0) and 1 year
Number of patients who experienced transient monocular blindness
Time frame: In the minute following intravitreal injection
IOP evolution in the glaucoma patient subgroup
Time frame: At baseline : just before injection (T0), just after injection (T1) and at 15 minutes (T15), 30 minutes (T30) and 45 minutes after injection (T45)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hussam EL CHEHAB, MD, FEBO study director
Sainte-Anne Military Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra ocular pressure Measure in people with Macular Diseases, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali CESANA (04 83 77 20 60 ext. +33, magali.cesana@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra Ocular Pressure (time frame: At baseline : just before injection (T0), just after injection (T1) and at 15 minutes (T15), 30 minutes (T30) and 45 minutes after injection (T45)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.