About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
High myopia (axial length > 26 mm or spherical equivalent < -6 diopters)
Angioid streaks
Moderate or severe diabetic retinopathy
History of diabetic macular edema
Trial population
Adult patients with exudative age-related macular degeneration followed in ophthalmology departments and private ophthalmology practices participating in the study.
Trial design
Cohort
Retrospective
Treatments tested in this trial
aflibercept 8 mg
DrugExposure 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Number of ophthalmology visits
Comparison of the number of ophthalmology consultations during the 12 months before and after the switch to aflibercept 8 mg.
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.
Sponsors and contacts
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