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Recruiting NCT07423429

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

Conditions: Exudative Age-Related Macular Degeneration

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Nantes University Hospital

Location: CHU Nantes - Ophthalmology Department Nantes Nantes

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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * High myopia (axial length \> 26 mm or spherical equivalent \< -6 diopters) * Angioid streaks * Moderate or severe diabetic retinopathy * History of diabetic macular edema * History of uveitis * History of retinal vein occlusion (branch or central) * History of pseudovitelliform macular dystrophy * Patient under legal guardianship or curatorship * Pregnant or breastfeeding women

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07423429). StuddyBuddy aggregates publicly available trial information.