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Идёт набор NCT07550777

Serum Cholinesterases, Paraoxonase, and Cardiovascular Risk After Intravitreal Bevacizumab

— Наблюдательное Diabete Mellitus Retina Vein Occlusion Age Macular Degeneration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: blood test.
Кому может быть актуально
Состояния в реестре: Diabete Mellitus, Retina Vein Occlusion, Age Macular Degeneration. Базовые параметры: 50 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Serum Acetylcholinesterase, Butyrylcholinesterase, Paraoxonase Activity, and Cardiovascular Risk Factors in Patients Treated With Intravitreal Bevacizumab

Обзор

Bevacizumab, an anti-VEGF (vascular endothelial growth factor) agent used in the treatment of diabetic retinopathy and macular edema associated with retinal vein occlusion, is commonly administered in ophthalmology clinics through intravitreal injection. The systemic use of bevacizumab has been associated with serious conditions such as thromboembolism and bleeding. Although intravitreal bevacizumab is administered in smaller amounts and has limited systemic circulation, it requires repeated injections over a long period. These long-term intravitreal anti-VEGF therapies may lead to adverse outcomes, particularly thromboembolism, due to systemic inhibition of VEGF. However, limited information is available regarding the potential effects of this treatment on the systemic and cardiovascular systems. To evaluate this risk, the study aims to assess changes in the activities of paraoxonase 1 (PON1), acetylcholinesterase (AChE), and butyrylcholinesterase (BChE), which are closely associated with lipid metabolism, coronary artery disease, and atherosclerosis. These enzymes are known biomarkers of cardiovascular health and play significant roles in protection against oxidative stress and inflammation. For this purpose, a case-control study is planned. Serum BChE and PON1 activities, as well as triglyceride (TG)/high-density lipoprotein (HDL) and TG/glucose ratios, will be determined in patients receiving repeated intravitreal bevacizumab injections and in control groups, and cardiovascular disease risk will be assessed. This study may help us better understand the safety profile of this treatment by revealing the effects of bevacizumab on serum enzyme activities and cardiovascular risk factors. These findings could contribute to optimizing treatment strategies in clinical practice.

Вмешательства

  • Процедура blood test
    Serum samples will be collected from the patient group included in the study starting from at least the second dose of intravitreal bevacizumab treatment. Serum samples will be collected within one week after the last injection.

Первичные конечные точки

  • Serum butyrylcholinesterase (BChE) activity [Срок оценки: Within 7 days after the most recent intravitreal bevacizumab injection]
Вторичные конечные точки (1)
  • Serum acetylcholinesterase (AChE) activity [Срок оценки: Within 7 days after the most recent intravitreal bevacizumab injection]

Критерии участия

Критерии включения

  • Age ≥ 55 years.
  • Ability to provide written informed consent.
  • Patient group: Diagnosis of macular edema secondary to diabetic retinopathy, retinal vein occlusion, or age-related macular degeneration, and having received repeated intravitreal bevacizumab injections (≥2 doses).
  • Control group: Healthy volunteers with no ocular pathology other than cataracts and not receiving intravitreal anti-VEGF treatment.

Критерии исключения

  • Chronic inflammatory disease.
  • Chronic infectious disease.
  • History of cardiovascular disease (e.g., coronary artery disease, heart failure, arrhythmia requiring treatment).
  • History of cerebrovascular disease (e.g., stroke, transient ischemic attack).
  • Any additional ocular pathology that may affect the study outcomes (other than the index retinal condition in the patient group and cataract in the control group), such as:

glaucoma

uveitis

retinal dystrophies

significant media opacity preventing adequate ocular evaluation

\- Use of systemic medications or conditions known to affect cholinesterase activity markedly

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ataturk University Research Hospital, Department of Ophthalmology — Erzurum

Идентификаторы

NCT: NCT07550777 · B.30.2.ATA.0.01.00/346

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗