Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration

Condition(s) studied

Investigational drug(s) / intervention(s)

aflibercept 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Nantes University Hospital trials in France

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