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

Sponsor
Nantes University Hospital
Study ID
NCT07423429
Status
Recruiting
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Conditions

  • Exudative Age-Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Feb 20, 2026
Start date
Feb 20, 2026
Status verified
Jun 2026
Primary completion
Oct 20, 2026
Completion
Oct 20, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in intravitreal injection interval [ Time Frame: From 12 months before switch to 12 months after switch to aflibercept 8 mg ]

Central Contacts