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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exudative Age-Related Macular Degeneration
• Intervention / Treatment: Drug: aflibercept 8 mg

Detailed Description

This is a multicenter, retrospective, real-world observational study conducted in patients with exudative age-related macular degeneration who were switched from a previous anti-VEGF therapy to aflibercept 8 mg as part of routine clinical care.

The study will include adult patients treated for exudative age-related macular degeneration for at least one year and switched to aflibercept 8 mg between January 2025 and July 2025 because of refractory disease or treatment dependence. Data will be collected retrospectively from medical records across participating centers in Western France.

Clinical outcomes will be assessed by comparing treatment intervals, number of intravitreal injections, number of ophthalmology visits, visual acuity, central macular thickness, and presence of intraretinal or subretinal fluid during the 12 months before and after the switch to aflibercept 8 mg. Safety outcomes will include the occurrence of ocular adverse events such as intraocular inflammation, endophthalmitis, and retinal complications.

Statistical analyses will include comparisons of quantitative and qualitative variables before and after the switch, as well as multivariable analyses to identify factors associated with greater extension of injection intervals.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Alexandra Poinas, PhD; Phone Number: +33 2 53 48 28 57; Email: alexandra.poinas@chu-nantes.fr
• Study Contact Backup: Name: Jean Baptiste DUCLOYER, MD, PhD; Phone Number: 02 40 08 34 01; Email: jeanbaptiste.ducloyer@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection-free interval without exudative recurrence	Difference in the longest injection interval without intraretinal or subretinal fluid before the switch and after 12 months of treatment with aflibercept 8 mg, or at the time of reswitch.	From 12 months before switch to 12 months after switch
Number of intravitreal injections	Comparison of the total number of intravitreal anti-VEGF injections during the 12 months before versus the 12 months after the switch to aflibercept 8 mg.	12 months before and 12 months after switch
Number of ophthalmology visits	Comparison of the number of ophthalmology consultations during the 12 months before and after the switch to aflibercept 8 mg.	12 months before and 12 months after switch
Change in visual acuity	Comparison of best-corrected visual acuity measured in logMAR units before the switch and 12 months after the switch to aflibercept 8 mg.	Baseline (before switch) and 12 months after switch
Change in central macular thickness	Comparison of central macular thickness measured by optical coherence tomography before the switch and 12 months after the switch to aflibercept 8 mg.	Baseline (before switch) and 12 months after switch
Presence of intraretinal or subretinal fluid	Assessment of the presence of intraretinal and/or subretinal fluid before the switch and 12 months after the switch to aflibercept 8 mg.	Baseline (before switch) and 12 months after switch
Reswitch to another anti-VEGF therapy	Proportion of patients switched from aflibercept 8 mg to another anti-VEGF agent and reasons for reswitch within 12 months.	Within 12 months after switch

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: aflibercept
• Other Study ID Numbers: AP_JBD_SG_afliwest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol + Article
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No