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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

High myopia (axial length > 26 mm or spherical equivalent < -6 diopters)

Angioid streaks

Moderate or severe diabetic retinopathy

History of diabetic macular edema

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Aflibercept 8 mg Switch Cohort1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From 12 months before switch to 12 months after switch
2

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.

Time frame
12 months before and 12 months after switch
3

Number of ophthalmology visits

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

Time frame
12 months before and 12 months after switch
4

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.

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

Other outcomes

Sponsors and contacts

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