Exudative Age-Related Macular Degeneration
Conditions
Brief 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. 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.
Interventions
DRUGaflibercept 8 mg
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.
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * History of pseudovitelliform macular dystrophy * Patient under legal guardianship or curatorship * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in intravitreal injection interval | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection-free interval without exudative recurrence | From 12 months before switch to 12 months after switch | 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. |
| Number of intravitreal injections | 12 months before and 12 months after switch | 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. |
| Number of ophthalmology visits | 12 months before and 12 months after switch | Comparison of the number of ophthalmology consultations during the 12 months before and after the switch to aflibercept 8 mg. |
| Change in visual acuity | Baseline (before switch) and 12 months after switch | Comparison of best-corrected visual acuity measured in logMAR units before the switch and 12 months after the switch to aflibercept 8 mg. |
| Change in central macular thickness | Baseline (before switch) and 12 months after switch | Comparison of central macular thickness measured by optical coherence tomography before the switch and 12 months after the switch to aflibercept 8 mg. |
| Presence of intraretinal or subretinal fluid | Baseline (before switch) and 12 months after switch | Assessment of the presence of intraretinal and/or subretinal fluid before the switch and 12 months after the switch to aflibercept 8 mg. |
| Reswitch to another anti-VEGF therapy | Within 12 months after switch | Proportion of patients switched from aflibercept 8 mg to another anti-VEGF agent and reasons for reswitch within 12 months. |
Countries
France
Contacts
CONTACTJean Baptiste DUCLOYER, MD, PhD
CONTACTAlexandra Poinas, PhD
Outcome results
None listed