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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Change in intravitreal injection interval [Срок оценки: From 12 months before switch to 12 months after switch to aflibercept 8 mg]

Вторичные конечные точки (7)

• Injection-free interval without exudative recurrence [Срок оценки: From 12 months before switch to 12 months after switch]
• Number of intravitreal injections [Срок оценки: 12 months before and 12 months after switch]
• Number of ophthalmology visits [Срок оценки: 12 months before and 12 months after switch]
• Change in visual acuity [Срок оценки: Baseline (before switch) and 12 months after switch]
• Change in central macular thickness [Срок оценки: Baseline (before switch) and 12 months after switch]
• Presence of intraretinal or subretinal fluid [Срок оценки: Baseline (before switch) and 12 months after switch]
• Reswitch to another anti-VEGF therapy [Срок оценки: Within 12 months after switch]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU Nantes - Ophthalmology Department — Nantes

Идентификаторы

NCT: NCT07423429 · AP_JBD_SG_afliwest

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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