NCT07423429 Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration
| NCT ID | NCT07423429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Exudative Age-Related Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-02-20 |
| Primary Completion | 2026-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-02-20 with a primary completion date of 2026-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07423429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Exudative Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07423429 currently recruiting?
Yes, NCT07423429 is actively recruiting participants. Contact the research team at jeanbaptiste.ducloyer@chu-nantes.fr for enrollment information.
Where is the NCT07423429 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT07423429 clinical trial?
NCT07423429 is sponsored by Nantes University Hospital. The trial plans to enroll 100 participants.