High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)

Обзор

The purpose of this study is to compare two treatment frequencies using EYLEA® HD (aflibercept 8mg) in patients with wet age-related macular degeneration (wAMD) that are currently treated with EYLEA® (aflibercept 2mg). EYLEA® HD is approved by Health Canada has been tested in large clinical trials involving thousands of patients around the world and has been shown effective in the treatment of wAMD. The treatment regimen used in these trials involved 3 initial monthly injections of EYLEA® HD followed by an extension of the treatment interval on the 4th visit. This was necessary since all patients in this study did not previously have treatment injections for wAMD. Currently there is not enough information on the best treatment regimen to use for patients that are switched to EYLEA® HD from EYLEA®. Health Canada currently recommends that EYLEA® HD is administered every month for the first 3 doses, followed by a treatment every 8 to 16 weeks. A total of 180 patients \>18 years of age will participate in this study, which will be conducted at the Clinique de Retine de l'Est in Montreal, Quebec, Canada.

Вмешательства

• Другое Maintenance
  Patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and maintain the current treatment interval that they had with EYLEA® (aflibercept 2mg), followed by an extension of therapy (or increase in treatment dosing interval) based on clinical response

Первичные конечные точки

• Central Retinal Thickness (CRT) [Срок оценки: 6 and 12 month]

Вторичные конечные точки (7)

• Visual Acuity [Срок оценки: 6 and 12 month]
• Number of injections [Срок оценки: 6 and 12 month]
• Adverse events [Срок оценки: 6 and 12 month]
• Presence of Subretinal Fluid (Yes/No) [Срок оценки: 6 months and 12 months]
• Presence of Intraretinal Fluid (Yes/No) [Срок оценки: 6 months and 12 months]
• Pigment Epithelial Detachment (PED) Type [Срок оценки: 6 months and 12 months]
• Pigment Epithelial Detachment (PED) Height [Срок оценки: 6 months and 12 months]

Критерии участия

Критерии включения

• Patients over the age of 18
• Patients with neovascular AMD
• Patients who have received aflibercept 2mg for a minimum of 3 loading injections plus 2 maintenance injections.
• Can include 1 or 2 eyes per patient if one or both meet study criteria.

Критерии исключения

• Patients with other maculopathy, including but not limited to:
• Polypoidal choroidal vasculopathy
• Macular dystrophies (ie. Pattern dystrophy, central areolar etc.)
• Toxic/drug induced maculopathies
• Disciform scar
• Subfoveal atrophy
• Previous Photodynamic Therapy (PDT) or focal laser
• Is currently enrolled in another clinical study or observational study
• Active use of a different agent in the fellow eye, to avoid cross-over effects of anti Vascular Endothelial Growth Factor (VEGF) administration to the fellow eye
• If the patient is pregnant

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Clinique de Retine de L'Est — Montreal

Идентификаторы

NCT: NCT07129239 · 23002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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