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NCT Number: NCT07423429

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

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.

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Key information

Conditions

Exudative Age-Related Macular Degeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in intravitreal injection interval

    Time frame: From 12 months before switch to 12 months after switch to aflibercept 8 mg

    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.

Secondary outcomes

  1. Injection-free interval without exudative recurrence

    Time frame: From 12 months before switch to 12 months after switch

    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.

  2. Number of intravitreal injections

    Time frame: 12 months before and 12 months after switch

    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.

  3. Number of ophthalmology visits

    Time frame: 12 months before and 12 months after switch

    Comparison of the number of ophthalmology consultations during the 12 months before and after the switch to aflibercept 8 mg.

  4. Change in visual acuity

    Time frame: Baseline (before switch) and 12 months after switch

    Comparison of best-corrected visual acuity measured in logMAR units before the switch and 12 months after the switch to aflibercept 8 mg.

  5. Change in central macular thickness

    Time frame: Baseline (before switch) and 12 months after switch

    Comparison of central macular thickness measured by optical coherence tomography before the switch and 12 months after the switch to aflibercept 8 mg.

  6. Presence of intraretinal or subretinal fluid

    Time frame: Baseline (before switch) and 12 months after switch

    Assessment of the presence of intraretinal and/or subretinal fluid before the switch and 12 months after the switch to aflibercept 8 mg.

  7. Reswitch to another anti-VEGF therapy

    Time frame: Within 12 months after switch

    Proportion of patients switched from aflibercept 8 mg to another anti-VEGF agent and reasons for reswitch within 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Poinas, PhD

CONTACT

[email protected]

+33 2 53 48 28 57

Jean Baptiste DUCLOYER, MD, PhD

CONTACT

[email protected]

02 40 08 34 01

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: AFLIWEST

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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