NCT07423429

Retrospective Multicenter Real-world Observational Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exudative Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-02-20
• Last updated: 2026-02-20