Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)

Официальное название

Multicentre, Randomised, Double-blind, Parallel-group, Phase III Study to Evaluate the Genetic Polymorphism Influence in the Response to Ranibizumab and Bevacizumab Treatment in Patients With Age-Associated Macular Degeneration.

Обзор

This is a phase III, multicenter, randomized double-blinded clinical trial with two parallel groups (ranibizumab and bevacizumab) and an observational follow-up of patients who meet elegibility criteria and decline participation due to treatment randomization. It will be performed involving 630 eyes from patients with wet age-related macular degeneration (wAMD) diagnosis without another eye disease. This clinical trial compares the treatment response for 3 years, considering genetic variants already studied between the eyes treated with one of the first options of anti-VEGF used in patients with wAMD, (ranibizumab) and the most cost-effective anti-VEGF (bevacizumab; off-label use)

Вмешательства

• Препарат Bevacizumab
  The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
• Препарат Ranibizumab Ophthalmic
  The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml

Первичные конечные точки

• Frequency of Genetic Polymorphism in VEGFA Associated With Anti-VEGF Treatment Response in AMD Patients [Срок оценки: From baseline, first dose, up to 3 years]

Вторичные конечные точки (11)

• Change in Visual Acuity Over Time in Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]
• Change in Retinal Fluid and Foveal Thickness Over Time as Measured by OCT in Patients With AMD Treated With Anti-VEGF Therapy [Срок оценки: Baseline, 6 months, 12 months, 24 months, 36 months]
• Distribution of Sex Among Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: At baseline]
• Distribution of Age at Diagnosis in Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: At baseline]
• Proportion of Smokers Among Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: At baseline]
• Weight of Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: At baseline]
• Height of Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: At baseline]
• Prevalence of Obesity in Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: At baseline]
• Prevalence of Hypertension in Patients With AMD Receiving Anti-VEGF Therapy [Срок оценки: At baseline]
• Number of Participants With Ocular and Systemic Adverse Events Associated With Intravitreal Anti-VEGF Therapy [Срок оценки: From intravitreal injection, up to 3 years]
• Total Direct Healthcare Cost per Patient for Anti-VEGF Therapy Over One Year From the Health System Perspective [Срок оценки: From baseline up to 1 year]

Критерии участия

Критерии включения

• Patients diagnosed with neovascular Age-related Macular Degeneration
• Age of 50 years or older.
• That at the discretion of the ophthalmologist has an indication of receiving treatment with an anti-VEGF agent as usual in clinical practice.
• Without previous treatment in the eye under study (no previous treatment for AMD).

Критерии исключения

• Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
• Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.
• Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
• High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months.
• Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma.
• Hypersensitivity to the active substance or to the excipients.
• Diabetic retinopathy documented.
• Pregnant or nursing (lactating) women.

Patients who meet elegibility criteria and decline participation due to treatment randomization, will participate in an observational follow-up, collecting saliva for the analysis of genetic polymorphisms and clinical data related to antiVEGF received out of the clinical trial and AV, OCT results and adverse events registered in medical records at 6m, 12m, 24m, 36m.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 4 центра

• Hospital Universitario de Canarias — San Cristóbal de La Laguna
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital la Esperanza — Barcelona
• Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz) — Madrid

Идентификаторы

NCT: NCT06952452 · ICI21/00025 · 2019-003204-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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