Actively Recruiting

Age: 50Years - 80Years
All Genders
Healthy Volunteers
NCT07550777

Serum Cholinesterases, Paraoxonase, and Cardiovascular Risk After Intravitreal Bevacizumab

Led by Ataturk University · Updated on 2026-04-24

180

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Serum Cholinesterases, Paraoxonase, and Cardiovascular Risk After Intravitreal Bevacizumab

Who Can Participate

Age: 50Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 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
  • Patient group: Having received repeated intravitreal bevacizumab injections (at least 2 doses)
  • Control group: Healthy volunteers with no ocular pathology other than cataracts
  • Control group: Not receiving intravitreal anti-VEGF treatment
Not Eligible

You will not qualify if you...

  • Chronic inflammatory disease
  • Chronic infectious disease
  • History of cardiovascular disease such as coronary artery disease, heart failure, or arrhythmia requiring treatment
  • History of cerebrovascular disease such as stroke or transient ischemic attack
  • Additional ocular pathology affecting study outcomes (other than the index retinal condition in patient group and cataract in control group), including glaucoma, uveitis, retinal dystrophies, or significant media opacity
  • Use of systemic medications or conditions known to markedly affect cholinesterase activity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ataturk University Research Hospital, Department of Ophthalmology

Erzurum, Erzurum, Turkey (Türkiye), 25240

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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