Serum Cholinesterases, Paraoxonase, and Cardiovascular Risk After Intravitreal Bevacizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood test.
- Who it may be relevant to
- Registry conditions: Diabete Mellitus, Retina Vein Occlusion, Age Macular Degeneration. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Serum Acetylcholinesterase, Butyrylcholinesterase, Paraoxonase Activity, and Cardiovascular Risk Factors in Patients Treated With Intravitreal Bevacizumab
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- Serum butyrylcholinesterase (BChE) activity [Time frame: Within 7 days after the most recent intravitreal bevacizumab injection]
Secondary outcome measures (1)
- Serum acetylcholinesterase (AChE) activity [Time frame: Within 7 days after the most recent intravitreal bevacizumab injection]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Ataturk University Research Hospital, Department of Ophthalmology — Erzurum
Identifiers
NCT: NCT07550777 · B.30.2.ATA.0.01.00/346