Age Macular Degeneration, Diabete Mellitus, Retina Vein Occlusion
Conditions
Keywords
bevacizumab, paraoxonase, retinal vein occlusion, age-related macular degeneration, diabetic retinopathy, acetylcholinesterase, butyrylcholinesterase
Brief summary
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
PROCEDUREblood 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.
Sponsors
Ataturk University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum butyrylcholinesterase (BChE) activity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum acetylcholinesterase (AChE) activity | Within 7 days after the most recent intravitreal bevacizumab injection | Measurement of serum acetylcholinesterase (AChE) activity in participants who received at least 2 consecutive intravitreal bevacizumab injections. Serum samples will be collected after the most recent injection, and AChE 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). |
Countries
Turkey (Türkiye)
Outcome results
None listed