Blood enzyme changes and heart risk after bevacizumab eye injections
Serum Acetylcholinesterase, Butyrylcholinesterase, Paraoxonase Activity, and Cardiovascular Risk Factors in Patients Treated With Intravitreal Bevacizumab
This tests whether repeated bevacizumab eye injections change blood enzymes linked to cardiovascular risk in people aged 55 and older treated for diabetic retinopathy, retinal vein occlusion, or age-related macular degeneration.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Ataturk University Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Erzurum, Erzurum) |
| Trial ID | NCT07550777 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of patients who have received repeated intravitreal bevacizumab injections and healthy volunteers, using blood tests to measure paraoxonase 1 (PON1), acetylcholinesterase (AChE), and butyrylcholinesterase (BChE) activities. Participants are adults aged 55 and older with macular edema from diabetic retinopathy, retinal vein occlusion, or age-related macular degeneration who have had at least two bevacizumab injections, while controls are healthy volunteers without ocular disease other than cataract. Key exclusions include chronic inflammatory or infectious disease, prior cardiovascular or cerebrovascular disease, and other ocular conditions such as glaucoma or uveitis that could affect results. All testing is conducted at a single center with blood draws performed for biochemical analysis and comparison between groups.
Who should consider this trial
Good fit: Ideal candidates are people aged 55 or older with macular edema due to diabetic retinopathy, retinal vein occlusion, or age-related macular degeneration who have received at least two intravitreal bevacizumab injections and have no history of cardiovascular, cerebrovascular, chronic inflammatory, or chronic infectious disease (healthy volunteers with only cataract are eligible as controls).
Not a fit: Patients with prior cardiovascular or cerebrovascular disease, chronic inflammatory or infectious conditions, or additional ocular pathologies such as glaucoma, uveitis, retinal dystrophies, or significant media opacity are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify blood enzyme changes that signal increased cardiovascular risk after repeated intravitreal bevacizumab and inform monitoring or preventive care.
How similar studies have performed: Systemic bevacizumab has been linked to thromboembolic events in other research, but the effects of repeated intravitreal bevacizumab on PON1 and cholinesterases and related cardiovascular risk are not well established and similar observational data are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erzurum, Erzurum
- Ataturk University Research Hospital, Department of Ophthalmology — Erzurum, Erzurum, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.