Exudative Age-Related Macular DegenerationAFLIWESTNCT07423429
Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration
An observational study of Exudative Age-Related Macular Degeneration, run by Nantes University Hospital at 1 site in France.
Trial summary
Age-related macular degeneration is a leading cause of visual impairment in older adults. In its exudative form, repeated intravitreal injections of anti-VEGF agents are required to control disease activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exudative Age-Related Macular Degeneration
- What is being tested?
- aflibercept 8 mg
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2026to 20 Oct 2026
- Phase
- Observational
- 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
Study population: Adult patients with exudative age-related macular degeneration followed in ophthalmology departments and private ophthalmology practices participating in the study.
Who may be able to join
- Adults (≥18 years) with exudative (neovascular) age-related macular degeneration
- Treated with intravitreal anti-VEGF therapy for more than 1 year
- Switched to aflibercept 8 mg before July 31, 2025
- Injection interval strictly less than 12 weeks prior to switch
Who cannot join
- High myopia (axial length > 26 mm or spherical equivalent < -6 diopters)
- Angioid streaks
- Moderate or severe diabetic retinopathy
- History of diabetic macular edema
- History of uveitis
- History of retinal vein occlusion (branch or central)
Show all 9Show fewer
- History of pseudovitelliform macular dystrophy
- Patient under legal guardianship or curatorship
- Pregnant or breastfeeding women
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
CHU Nantes - Ophthalmology Department
Nantes, Nantes, 44000
Alexandra Poinas, PhD, +33 2 40 08 33 33, alexandra.poinas@chu-nantes.fr
About this study
Official title: Retrospective Multicenter Real-world Observational Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration
Age-related macular degeneration is a leading cause of visual impairment in older adults. In its exudative form, repeated intravitreal injections of anti-VEGF agents are required to control disease activity. A new formulation of aflibercept at a higher dose (8 mg) has been developed with the aim of extending the interval between injections.
This multicenter retrospective real-world observational study will evaluate the effect of switching to aflibercept 8 mg in patients with refractory or dependent exudative age-related macular degeneration. Clinical data collected during routine care will be analyzed to compare injection intervals, treatment burden, visual outcomes, anatomical outcomes, and safety before and after the switch.
Read the detailed description
This is a multicenter, retrospective, real-world observational study conducted in patients with exudative age-related macular degeneration who were switched from a previous anti-VEGF therapy to aflibercept 8 mg as part of routine clinical care.
The study will include adult patients treated for exudative age-related macular degeneration for at least one year and switched to aflibercept 8 mg between January 2025 and July 2025 because of refractory disease or treatment dependence. Data will be collected retrospectively from medical records across participating centers in Western France.
Clinical outcomes will be assessed by comparing treatment intervals, number of intravitreal injections, number of ophthalmology visits, visual acuity, central macular thickness, and presence of intraretinal or subretinal fluid during the 12 months before and after the switch to aflibercept 8 mg. Safety outcomes will include the occurrence of ocular adverse events such as intraocular inflammation, endophthalmitis, and retinal complications.
Statistical analyses will include comparisons of quantitative and qualitative variables before and after the switch, as well as multivariable analyses to identify factors associated with greater extension of injection intervals.
- Being tested
- aflibercept 8 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aflibercept 8 mgDrug
Exposure of interest corresponding to a switch to intravitreal aflibercept 8 mg administered according to routine clinical practice for the treatment of exudative age-related macular degeneration.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept 8 mg Switch Cohort | Patients with exudative age-related macular degeneration switched from a previous anti-VEGF therapy to aflibercept 8 mg as part of routine clinical care. Receives: Drug: aflibercept 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intravitreal injection interval
Difference in the number of weeks between intravitreal anti-VEGF injections before switching to aflibercept 8 mg and after 12 months of treatment with aflibercept 8 mg, or at the last observed interval in case of switch to another molecule.
Measured: From 12 months before switch to 12 months after switch to aflibercept 8 mg
Secondary outcomes (7)
Injection-free interval without exudative recurrence
Difference in the longest injection interval without intraretinal or subretinal fluid before the switch and after 12 months of treatment with aflibercept 8 mg, or at the time of reswitch.
Measured: From 12 months before switch to 12 months after switch
Number of intravitreal injections
Comparison of the total number of intravitreal anti-VEGF injections during the 12 months before versus the 12 months after the switch to aflibercept 8 mg.
Measured: 12 months before and 12 months after switch
Number of ophthalmology visits
Comparison of the number of ophthalmology consultations during the 12 months before and after the switch to aflibercept 8 mg.
Measured: 12 months before and 12 months after switch
Change in visual acuity
Comparison of best-corrected visual acuity measured in logMAR units before the switch and 12 months after the switch to aflibercept 8 mg.
Measured: Baseline (before switch) and 12 months after switch
Change in central macular thickness
Comparison of central macular thickness measured by optical coherence tomography before the switch and 12 months after the switch to aflibercept 8 mg.
Measured: Baseline (before switch) and 12 months after switch
Presence of intraretinal or subretinal fluid
Assessment of the presence of intraretinal and/or subretinal fluid before the switch and 12 months after the switch to aflibercept 8 mg.
Measured: Baseline (before switch) and 12 months after switch
Reswitch to another anti-VEGF therapy
Proportion of patients switched from aflibercept 8 mg to another anti-VEGF agent and reasons for reswitch within 12 months.
Measured: Within 12 months after switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start20 Feb 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423429
- Sponsor's protocol ID
- AP_JBD_SG_afliwest
- Acronym
- AFLIWEST
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol + Article
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter Real-world Observational Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07423429
- Acronym / sponsor ID
- AFLIWEST / AP_JBD_SG_afliwest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 20 Feb 2026 (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.
Age-related macular degeneration is a leading cause of visual impairment in older adults. In its exudative form, repeated intravitreal injections of anti-VEGF agents are required to control disease activity. A new formulation of aflibercept at a higher dose (8 mg) has been developed with the aim of extending the interval between injections.
This multicenter retrospective real-world observational study will evaluate the effect of switching to aflibercept 8 mg in patients with refractory or dependent exudative age-related macular degeneration. Clinical data collected during routine care will be analyzed to compare injection intervals, treatment burden, visual outcomes, anatomical outcomes, and safety before and after the switch.
Detailed description
This is a multicenter, retrospective, real-world observational study conducted in patients with exudative age-related macular degeneration who were switched from a previous anti-VEGF therapy to aflibercept 8 mg as part of routine clinical care.
The study will include adult patients treated for exudative age-related macular degeneration for at least one year and switched to aflibercept 8 mg between January 2025 and July 2025 because of refractory disease or treatment dependence. Data will be collected retrospectively from medical records across participating centers in Western France.
Clinical outcomes will be assessed by comparing treatment intervals, number of intravitreal injections, number of ophthalmology visits, visual acuity, central macular thickness, and presence of intraretinal or subretinal fluid during the 12 months before and after the switch to aflibercept 8 mg. Safety outcomes will include the occurrence of ocular adverse events such as intraocular inflammation, endophthalmitis, and retinal complications.
Statistical analyses will include comparisons of quantitative and qualitative variables before and after the switch, as well as multivariable analyses to identify factors associated with greater extension of injection intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept 8 mg Switch Cohort | – | Drug: aflibercept 8 mgPatients with exudative age-related macular degeneration switched from a previous anti-VEGF therapy to aflibercept 8 mg as part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with exudative age-related macular degeneration followed in ophthalmology departments and private ophthalmology practices participating in the study.
Key inclusion criteria (4 listed)
- Adults (≥18 years) with exudative (neovascular) age-related macular degeneration
- Treated with intravitreal anti-VEGF therapy for more than 1 year
- Switched to aflibercept 8 mg before July 31, 2025
- Injection interval strictly less than 12 weeks prior to switch
Key exclusion criteria (9 listed)
- High myopia (axial length > 26 mm or spherical equivalent < -6 diopters)
- Angioid streaks
- Moderate or severe diabetic retinopathy
- History of diabetic macular edema
- History of uveitis
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 |
|---|---|---|
| aflibercept 8 mgExposure of interest corresponding to a switch to intravitreal aflibercept 8 mg administered according to routine clinical practice for the treatment of exudative age-related macular degeneration. | Drug | Aflibercept 8 mg Switch Cohort |
Primary outcome
Change in intravitreal injection interval
Time frame: From 12 months before switch to 12 months after switch to aflibercept 8 mg
Difference in the number of weeks between intravitreal anti-VEGF injections before switching to aflibercept 8 mg and after 12 months of treatment with aflibercept 8 mg, or at the last observed interval in case of switch to another molecule.
7 secondary outcomes
Injection-free interval without exudative recurrence
Time frame: From 12 months before switch to 12 months after switch
Number of intravitreal injections
Time frame: 12 months before and 12 months after switch
Number of ophthalmology visits
Time frame: 12 months before and 12 months after switch
Change in visual acuity
Time frame: Baseline (before switch) and 12 months after switch
Change in central macular thickness
Time frame: Baseline (before switch) and 12 months after switch
Presence of intraretinal or subretinal fluid
Time frame: Baseline (before switch) and 12 months after switch
Reswitch to another anti-VEGF therapy
Time frame: Within 12 months after switch
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 25 Jun 2026.
- Individual participant dataSharing planned: Yes. Study Protocol + Article
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exudative Age-Related Macular Degeneration, run by Nantes University Hospital 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 4 inclusion and 9 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 25 Jun 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 Jean Baptiste DUCLOYER, MD, PhD (02 40 08 34 01, jeanbaptiste.ducloyer@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intravitreal injection interval (time frame: From 12 months before switch to 12 months after switch to aflibercept 8 mg). 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 25 Jun 2026.