跳至主要内容
临床试验/NCT07550777
NCT07550777招募中不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Serum butyrylcholinesterase (BChE) activity

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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:
  • retinal dystrophies
  • significant media opacity preventing adequate ocular evaluation
  • - Use of systemic medications or conditions known to affect cholinesterase activity markedly

研究组 & 干预措施

diabetic macular edema

干预措施: blood test (Procedure)

retinal vascular occ

干预措施: blood test (Procedure)

age macular degeneration

干预措施: blood test (Procedure)

control

干预措施: blood test (Procedure)

结局指标

主要结局

Serum butyrylcholinesterase (BChE) activity

时间窗: Within 7 days after the most recent intravitreal bevacizumab injection

Description: Measurement of serum butyrylcholinesterase (BChE) activity in participants who received at least 2 consecutive intravitreal bevacizumab injections. Serum samples will be collected after the most recent injection, and BChE activity will be compared among subgroups defined by the number of previous consecutive injections (early: 2-3 doses; mid: 4-6 doses; long: \>6 doses).

次要结局

  • Serum acetylcholinesterase (AChE) activity(Within 7 days after the most recent intravitreal bevacizumab injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Büşra Çalışkan

assistant professor

Ataturk University

研究点 (1)

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