Diabete MellitusNCT07550777
Serum Cholinesterases, Paraoxonase, and Cardiovascular Risk After Intravitreal Bevacizumab
An observational study of Diabete Mellitus and Retina Vein Occlusion, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus, Retina Vein Occlusion, Age Macular Degeneration
- What is being tested?
- blood test
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2025to 10 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient group consists of individuals receiving repeated doses of intravitreal bevacizumab treatment for diabetic macular edema, retinal vein occlusion, and age-related macular degeneration-related macular edema, along with a control group (the control group will also be divided into two subgroups: individuals with diabetes but without macular edema or diabetic retinopathy, and completely healthy individuals).
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- uveitis
- retinal dystrophies
- significant media opacity preventing adequate ocular evaluation
- Use of systemic medications or conditions known to affect cholinesterase activity markedly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Research Hospital, Department of Ophthalmology
Erzurum, Erzurum, 25240
Büşra çalışkan, +905342700488, drbusracaliskan@gmail.com
About this study
Official title: Serum Acetylcholinesterase, Butyrylcholinesterase, Paraoxonase Activity, and Cardiovascular Risk Factors in Patients Treated With Intravitreal Bevacizumab
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.
- Being tested
- blood test
- Keywords
- bevacizumab, paraoxonase, retinal vein occlusion, age-related macular degeneration, diabetic retinopathy, acetylcholinesterase, butyrylcholinesterase
- Medical subject headings
- Diabetes Mellitus, Retinal Vein Occlusion, Macular Degeneration, Diabetic Retinopathy, Pain, Butyrylcholinesterase deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| diabetic macular edema | Not described Receives: Procedure: blood test | |
| retinal vascular occ | Not described Receives: Procedure: blood test | |
| age macular degeneration | Not described Receives: Procedure: blood test | |
| control | Not described Receives: Procedure: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum butyrylcholinesterase (BChE) activity
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).
Measured: Within 7 days after the most recent intravitreal bevacizumab injection
Secondary outcomes (1)
Serum acetylcholinesterase (AChE) activity
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).
Measured: Within 7 days after the most recent intravitreal bevacizumab injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start3 Nov 2025
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Çalışkan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550777
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/346
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Acetylcholinesterase, Butyrylcholinesterase, Paraoxonase Activity, and Cardiovascular Risk Factors in Patients Treated With Intravitreal Bevacizumab
- ClinicalTrials.gov ID
- NCT07550777
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/346
- Keywords
- bevacizumab, paraoxonase, retinal vein occlusion, age-related macular degeneration, diabetic retinopathy, acetylcholinesterase, butyrylcholinesterase
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diabetic macular edema | – | Procedure: blood test |
| retinal vascular occ | – | Procedure: blood test |
| age macular degeneration | – | Procedure: blood test |
| control | – | Procedure: blood test |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient group consists of individuals receiving repeated doses of intravitreal bevacizumab treatment for diabetic macular edema, retinal vein occlusion, and age-related macular degeneration-related macular edema, along with a control group (the control group will also be divided into two subgroups: individuals with diabetes but without macular edema or diabetic retinopathy, and completely healthy individuals).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testSerum 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. | Procedure or surgery | age macular degeneration, control, diabetic macular edema, retinal vascular occ |
Primary outcome
Serum butyrylcholinesterase (BChE) activity
Time frame: 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).
1 secondary outcome
Serum acetylcholinesterase (AChE) activity
Time frame: Within 7 days after the most recent intravitreal bevacizumab injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ataturk University Research Hospital, Department of Ophthalmology
Erzurum, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Mellitus and Retina Vein Occlusion, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum butyrylcholinesterase (BChE) activity (time frame: Within 7 days after the most recent intravitreal bevacizumab injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.