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

NCT07423429 | Not Yet Recruiting

• 1 other identifier: AP_JBD_SG_afliwest
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exudative Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change in intravitreal injection interval

  Difference in the number of weeks between intravitreal anti-VEGF injections before switching to aflibercept 8 mg and after 12 months of treatment with aflibercept 8 mg, or at the last observed interval in case of switch to another molecule.

  From 12 months before switch to 12 months after switch to aflibercept 8 mg

Secondary Outcomes (7)

• Injection-free interval without exudative recurrence

  From 12 months before switch to 12 months after switch

• Number of intravitreal injections

  12 months before and 12 months after switch

• Number of ophthalmology visits

  12 months before and 12 months after switch

• Change in visual acuity

  Baseline (before switch) and 12 months after switch

• Change in central macular thickness

  Baseline (before switch) and 12 months after switch

Study Arms (1)

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.

Drug: aflibercept 8 mg

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.

Aflibercept 8 mg Switch Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with exudative age-related macular degeneration followed in ophthalmology departments and private ophthalmology practices participating in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Jean Baptiste DUCLOYER, MD, PhD

CONTACT

02 40 08 34 01; jeanbaptiste.ducloyer@chu-nantes.fr

Alexandra Poinas, PhD

CONTACT

+33 2 53 48 28 57; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL