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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept 8 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 12 months before switch to 12 months after switch to aflibercept 8 mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 12 months before switch to 12 months after switch |
| Number of intravitreal injections |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with exudative age-related macular degeneration followed in ophthalmology departments and private ophthalmology practices participating in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Baptiste DUCLOYER, MD, PhD | Contact | 02 40 08 34 01 | jeanbaptiste.ducloyer@chu-nantes.fr | |
| Alexandra Poinas, PhD | Contact | +33 2 53 48 28 57 | alexandra.poinas@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes - Ophthalmology Department | Recruiting | Nantes | Nantes | 44000 | France |
Study Protocol + Article
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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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. |
| 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. | 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. | 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. | 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. | 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. | Within 12 months after switch |