Retrospective Multicenter Real-world Observational 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
- Not Yet 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 — 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.
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
- Start date
- Feb 28, 2026
- Status verified
- Feb 2026
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: Aflibercept 8 mg Switch CohortPatients 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
- Jean Baptiste DUCLOYER, MD, PhD02 40 08 34 01
- Alexandra Poinas, PhD+33 2 53 48 28 57